Archive for category JOB OPENINGS
Jobs – April, 2013
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on April 3, 2013
For the opportunities below, please send resume at wd_darshana at hotmail dot com. Please indicate in the email how closely the job description matches your background and identify gaps, if any. Also, indicate your current compensation and compensation expectations.
Python Programmer – Sunnyvale, CA
A contract engineering company has an immediate need for Programmer with Python expertise for about 40 hours of work. An existing test program written in Python collects data and prints it. The data needs to be written to an Access database residing in another computer on a network. The company is looking for someone to make this change. The right person needs to be experienced with Python and understand how to write data to a database from Python. The author of the original program is available for assistance.
Quality Engineer – SF, CA
This position reports to the Vice President of QA and Regulatory Compliance and supports Design Control, Manufacturing and Quality System for compliance to FDA and ISO requirements.
The candidate for this position will be on a team including members from Engineering, Development, Regulatory Affairs, Clinical Research and suppliers on quality-related issues.
Essential Functions: Identify and participate in implementing proactive quality improvements; Understand, communicate and integrate US and OUS regulatory standards (GMP, QSR, ISO, MDD and AIMDD) in V&V and operations; Manage supplier approval process and supplier audit program to ensure high-quality manufacturing capabilities; develop supplier relationships and perform source inspections; Investigate and drive closure of CAPAs for product and Quality System improvements; Manage complaint process; drive investigations and address failure root causes; Establish and revise specifications, interpret requirements to develop product test plans and specification documentation; Evaluate existing processes for process improvements and economy-of-scale efficiencies to improve cost-savings and product quality while managing technical and compliance risks; Write, review and approve validation documents related to product, processes, facilities and equipment; Participate as an audit team member for internal audits; assist in FDA, State, and ISO Inspections; Support risk management; perform risk analyses and track to requirements; Support company goals and objectives, policies and procedures; Perform other duties as assigned.
Desired Skills & Experience: BS in Engineering, Chemistry, Biology or related field. MS desirable; Minimum 5 years’ experience in medical device Quality Engineering, manufacturing scale-up or process engineering; Thorough understanding of FDA QSR and ISO 13485 requirements; experience with AIMDD desirable; Exhibit good problem solving and analytical skills; Skilled in MS Office Suite (Word, Excel, etc.), Visio and statistical software; Self-starter who can thrive in a fast-paced environment and independently manage work priorities; Working knowledge of design control, process validation and statistics, including DOE; Knowledge of electronics assembly, testing and experience with clean rooms preferred; Effective interpersonal skills, ability to guide and influence others; Effective verbal and written communication skills.
Quality Engineer with Injection Molding Experience- Soquel, CA — permanent, full-time
Responsibilities: Write FEMAs, review and write protocols and reports for new products; Be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes, Maintain facility measurement equipment calibration program; Collate and analyze manufacturing data for warranty and nonconformance to determine and report product quality trends; Conduct analysis of inspection and tests of a routine degree of complexity & provide recommendations; Develop quality control inspection requirements & techniques to achieve measured improvement; Implement the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action; Support receiving, in-process and final inspection of various components & subassemblies for medical device products to support quality compliance & shipment goals; Assist in development & implementation of quality systems processes; Attend product meetings with engineering, sales, support, marketing, and customers to address product requirements, customer concerns and training issues; Work toward & support Company/Department goals including QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate; Qualify and implement document changes involving product or process changes; Coordinate reporting, analysis, & resolution of material non-conformance incidences; Provide support in the timely resolution of product complaints and/or safety issues; Conduct quality audits and develop subsequent preventive action programs; Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies; Perform Supplier Quality Audits and as appropriate Internal Quality System Audits; identify root cause of non-compliance and ensure timely/ effective corrections and/or corrective / preventive actions are implemented; Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests; Report MRB performance metrics and maintain corrective action database; Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions.
Requirements: Bachelor of Science in Quality, Business, Mechanical Engineering, or related field, plus 5-7 years experience in Medical Device Quality, Regulatory, or Manufacturing environment is required. Also required, hands-on manufacturing experience in mechanical or medical device assemblies and working knowledge of desktop computer office software, Visio Tools, CAD software and e-mails. Experience as an ISO Lead Auditor and working knowledge of US and international medical device regulations, desirable and CQE, CQA certification, a plus. Experience with plastics and injection molding a HUGE plus.
Digital Signal Processing Specialist with Time Series Signal Processing of Biological Data- SF, CA
There is an opening for Digital Signal Processing Specialist, with excellent DSP skills to join a multi-disciplinary engineers, designers and experts from the entertainment, healthcare, research, and biotech industries – for revenue generating consumer oriented medical device.
Required Skills & Experience: Excellent skills and eagerness to expand knowledge around DSP for consumer products, the consumer health industry and wearable devices; Deep skill set and experience in DSP techniques, in particular for biological signal processing. A signal processing specialist with a minimum of 5 years experience in digital signal processing, preferably including experience relating to biological data; Proficiency in common DSP techniques including adaptive filters, noise cancellation and pattern recognition. Preferred skills include: Experience in algorithm development based on physiological parameters such as heart rate, temperature, GSR or body motion; Experience working with optical sensing technologies and engineering for consumer devices; and Python expertise. Experience in time-series signal processing of relevant biological data is required. Image processing with bio or medical experience without a time component is not sufficient. Communication and A/V have the component, but are not biologically relevant and therefore not suitable for this opportunity.
Responsibilities: Lead the development of algorithms based on the signals from existing advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into consumer products.
Prototype Hardware/Firmware Design Engineer – SF
There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus.
Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology.
Analog Design Engineer – Sunnyvale, CA
A Contract Engineering company located in Sunnyvale, CA has an immediate part-time contract opportunity for Analog Design Engineer, that is likely to become permanent in 3-6 months. Minimum 10 years of experience with analog circuit design, including amplifiers, ADCs, power supplies, and sensor signal conditioning is required. Also required, experience with digital design and ability to work with digital engineers to develop successful integrated products. Experience with signal integrity and/or RF design a plus.
The person must work well on a team, have good communication skills, and be able to adjust quickly in a fast paced environment where many designs are done simultaneously. This is a challenging and rewarding opportunity for the right person.
JOBS – March, 2013
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on March 26, 2013
For the opportunities below, please send resume at wd_darshana at hotmail dot com. Please indicate in the email how closely the job description matches your background and identify gaps, if any. Also, indicate your current compensation and compensation expectations.
Machine Learning Specialist – San Francisco, CA
A revenue generating, remote health monitoring company in San Francisco Bay Area, has an immediate opening for Machine Learning Specialist.
Requirements: Minimum 5 years experience in creating high-performance classifiers, preferably working on biological data. Deep knowledge, skills and experience in machine learning techniques, in particular for processing large databases of biological information. Should be proficient and able to design, operate and validate intelligent systems from scratch. Excellent written, verbal and teamwork skills. Highly preferred: Relevant bio experience, such as working with biological signal databases; Experience in engineering for consumer devices/services; and Python expertise.
Responsibilities: Lead the development of algorithms based on the signals from our advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into our consumer products.
Senior Manufacturing Engineer – Fremont, CA
Market leading company in providing innovative diagnostic and therapeutic products & services, located in Fremont, CA, has an immediate opening for Senior Manufacturing Engineer.
Responsibilities: Provide manufacturing expertise in the area of transducer wafer fabrication, PZT wafer processing. Use hand on skills to perform engineering work typically including one or all of the following: process/product improvements, test of materials, preparation of specifications, process study, evaluation of process materials, product design, report preparation and ECO documentation. Develop methods and tools to create processes and designs that are robust and able to be manufactured economically. Implement process changes manufacturing capabilities, production schedules, and other considerations to facilitate production process and design releases in accordance with business goals. Implement statistical process controls, Six Sigma tools and methodologies.
Projects – Manufacturing Engineering in Transducer Production
- Plan and coordinate manufacturing development activities around the existing transducer manufacturing process and design
- Coordinate the installation of new process equipment for transducer manufacturing which includes IQ, OQ & PQ of equipment
- Support the manufacturing operation on a daily basis to assure production of product. Provide ongoing manufacturing support in order to help the team meet its business objectives of quality, output and costs
- Represent manufacturing engineering on a project, product, and/or process development activity by bringing forth the utilization of GMP and DFMA methodologies to ensure and improve efficiencies and product designs
- Execute the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems where applicable
Production Support
- Apply Six Sigma tools and methodologies within transducer manufacturing to reduce cost and improve yields
- Troubleshoot design and process issues, implement improvements, and support all other daily activities such as NCMR (non-conforming material review), re-work, and change orders
- Analyze processes and create methods for process and quality monitoring including development of and reporting of metrics.
Technical Documentation and Training
- Write and review documentation: Manufacturing Process Instructions (MPI’s) Test Process Instructions (TPI’s), test protocols, validation protocols, new processes as well as all applicable documentation
- Provide reference to technical resources (technicians, engineers and assemblers) to ensure drawings, work instructions, methods are fully defined and validated and able to be effectively conveyed to the production staff
Requirements: BS in Engineering plus 5-9 years experience as Manufacturing Engineer is required. Also required, ability to assimilate technical concepts quickly and present technical information clearly; moderate to high level of computer proficiency including MS Office & SolidWorks; demonstrated expertise in a variety of process technologies and manufacturing environments; ability to lead & manage initiatives and small scale projects, experience & understanding of abrasive cutting process, wafer dicing and wafer back thinning; Ceramic or PZT processing experience; and some knowledge of acoustics.
Quality Engineer with Injection Molding Experience- Soquel, CA — permanent, full-time
Responsibilities: Write FEMAs, review and write protocols and reports for new products; Be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes, Maintain facility measurement equipment calibration program; Collate and analyze manufacturing data for warranty and nonconformance to determine and report product quality trends; Conduct analysis of inspection and tests of a routine degree of complexity & provide recommendations; Develop quality control inspection requirements & techniques to achieve measured improvement; Implement the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action; Support receiving, in-process and final inspection of various components & subassemblies for medical device products to support quality compliance & shipment goals; Assist in development & implementation of quality systems processes; Attend product meetings with engineering, sales, support, marketing, and customers to address product requirements, customer concerns and training issues; Work toward & support Company/Department goals including QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate; Qualify and implement document changes involving product or process changes; Coordinate reporting, analysis, & resolution of material non-conformance incidences; Provide support in the timely resolution of product complaints and/or safety issues; Conduct quality audits and develop subsequent preventive action programs; Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies; Perform Supplier Quality Audits and as appropriate Internal Quality System Audits; identify root cause of non-compliance and ensure timely/ effective corrections and/or corrective / preventive actions are implemented; Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests; Report MRB performance metrics and maintain corrective action database; Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions.
Requirements: Bachelor of Science in Quality, Business, Mechanical Engineering, or related field, plus 5-7 years experience in Medical Device Quality, Regulatory, or Manufacturing environment is required. Also required, hands-on manufacturing experience in mechanical or medical device assemblies and working knowledge of desktop computer office software, Visio Tools, CAD software and e-mails. Experience as an ISO Lead Auditor and working knowledge of US and international medical device regulations, desirable and CQE, CQA certification, a plus. Experience with plastics and injection molding a HUGE plus.
Digital Signal Processing Specialist with Time Series Signal Processing of Biological Data- SF, CA
There is an opening for Digital Signal Processing Specialist, with excellent DSP skills to join a multi-disciplinary engineers, designers and experts from the entertainment, healthcare, research, and biotech industries – for revenue generating consumer oriented medical device.
Required Skills & Experience: Excellent skills and eagerness to expand knowledge around DSP for consumer products, the consumer health industry and wearable devices; Deep skill set and experience in DSP techniques, in particular for biological signal processing. A signal processing specialist with a minimum of 5 years experience in digital signal processing, preferably including experience relating to biological data; Proficiency in common DSP techniques including adaptive filters, noise cancellation and pattern recognition. Preferred skills include: Experience in algorithm development based on physiological parameters such as heart rate, temperature, GSR or body motion; Experience working with optical sensing technologies and engineering for consumer devices; and Python expertise. Experience in time-series signal processing of relevant biological data is required. Image processing with bio or medical experience without a time component is not sufficient. Communication and A/V have the component, but are not biologically relevant and therefore not suitable for this opportunity.
Responsibilities: Lead the development of algorithms based on the signals from existing advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into consumer products.
Prototype Hardware/Firmware Design Engineer – SF
There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus.
Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology.
Jobs – February, 2013 — (Software, Hardware, Quality, Clinical)
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on February 6, 2013
For the opportunities below, please send resume at wd_darshana at hotmail dot com. Please indicate in the email how closely the job description matches your background and identify gaps, if any. Also, indicate your current compensation and compensation expectations.
Prototype Hardware/Firmware Design Engineer – SF — full time
There is an immediate full-time opening for Prototype Hardware/ Firmware Design Engineer in San Francisco, CA to join a multi-disciplinary team of engineers, designers and experts from the entertainment, healthcare, research, and biotech industries. This opportunity requires MS or PhD in Electrical Engineering and excellent sensor design skills plus 5+ years extensive HW/FW design experience for consumer products in integrating and developing novel sensor applications, especially in wearable consumer or medical devices. Also required, expertise in design, prototyping and miniaturization of analog and digital circuits, and proficiency in development of embedded firmware and implementation of embedded DSP. Consumer health industry and wearable device experience, a huge plus.
Responsibilities include: Conceive of and prototype novel sensing technologies, and demonstrate proof-of-concept in wearable form factor; Design, assemble, test, analyze, debug, and rework prototype sensor circuits that interface with and/or include microcontrollers or other embedded processors; Capture schematic circuit diagrams, design printed circuit boards and facilitate their fabrication and assembly; Develop, prototype and debug embedded firmware and code architecture; Interact with device development team to productize new sensor technology.
Machine Learning Specialist
Requirements: Minimum 5 years experience in creating high-performance classifiers, preferably working on biological data. Deep knowledge, skills and experience in machine learning techniques, in particular for processing large databases of biological information. Should be proficient and able to design, operate and validate intelligent systems from scratch. Excellent written, verbal and teamwork skills. Highly preferred: Relevant bio experience, such as working with biological signal databases; Experience in engineering for consumer devices/services; and Python expertise.
Responsibilities: Lead the development of algorithms based on the signals from our advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into our consumer products.
Quality Engineer with Injection Molding Experience- Soquel, CA — permanent, full-time
Responsibilities: Write FEMAs, review and write protocols and reports for new products; Be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes, Maintain facility measurement equipment calibration program; Collate and analyze manufacturing data for warranty and nonconformance to determine and report product quality trends; Conduct analysis of inspection and tests of a routine degree of complexity & provide recommendations; Develop quality control inspection requirements & techniques to achieve measured improvement; Implement the Failure Analysis Process for internal and external nonconforming product to determine appropriate corrective action; Support receiving, in-process and final inspection of various components & subassemblies for medical device products to support quality compliance & shipment goals; Assist in development & implementation of quality systems processes; Attend product meetings with engineering, sales, support, marketing, and customers to address product requirements, customer concerns and training issues; Work toward & support Company/Department goals including QSR and ISO compliance, revenues, training utilization, customer satisfaction, and others as appropriate; Qualify and implement document changes involving product or process changes; Coordinate reporting, analysis, & resolution of material non-conformance incidences; Provide support in the timely resolution of product complaints and/or safety issues; Conduct quality audits and develop subsequent preventive action programs; Assist Regulatory Affairs Department in the preparation of audits and reports for regulatory agencies; Perform Supplier Quality Audits and as appropriate Internal Quality System Audits; identify root cause of non-compliance and ensure timely/ effective corrections and/or corrective / preventive actions are implemented; Drive effective root cause corrective action through internal and supplier surveillance and corrective action requests; Report MRB performance metrics and maintain corrective action database; Review and report in-process data from manufacturing processes and facilitate corrective and preventive actions.
Requirements: Bachelor of Science in Quality, Business, Mechanical Engineering, or related field, plus 5-7 years experience in Medical Device Quality, Regulatory, or Manufacturing environment is required. Also required, hands-on manufacturing experience in mechanical or medical device assemblies and working knowledge of desktop computer office software, Visio Tools, CAD software and e-mails. Experience as an ISO Lead Auditor and working knowledge of US and international medical device regulations, desirable and CQE, CQA certification, a plus. Experience with plastics and injection molding a HUGE plus.
Digital Signal Processing Specialist with Time Series Signal Processing of Biological Data- SF, CA
There is an opening for Digital Signal Processing Specialist, with excellent DSP skills to join a multi-disciplinary engineers, designers and experts from the entertainment, healthcare, research, and biotech industries – for revenue generating consumer oriented medical device.
Required Skills & Experience: Excellent skills and eagerness to expand knowledge around DSP for consumer products, the consumer health industry and wearable devices; Deep skill set and experience in DSP techniques, in particular for biological signal processing. A signal processing specialist with a minimum of 5 years experience in digital signal processing, preferably including experience relating to biological data; Proficiency in common DSP techniques including adaptive filters, noise cancellation and pattern recognition. Preferred skills include: Experience in algorithm development based on physiological parameters such as heart rate, temperature, GSR or body motion; Experience working with optical sensing technologies and engineering for consumer devices; and Python expertise. Experience in time-series signal processing of relevant biological data is required. Image processing with bio or medical experience without a time component is not sufficient. Communication and A/V have the component, but are not biologically relevant and therefore not suitable for this opportunity.
Responsibilities: Lead the development of algorithms based on the signals from existing advanced multi-sensing device, both in real time and on databases of saved sensor data; Work on top secret projects pertaining to future product offerings; Work closely science and devices teams to integrate the work into consumer products.
Software Developer with Cloud Experience – Detroit, MI (12 mo. contract opportunity)
This position requires at least 2 years of experience with RedHat products in “cloud” (Cloud computing is the use of computing resources (hardware and software that are delivered as a service over a network) typically the internet.
Responsibilities:
*Help build out a new Red Hat Enterprise Linux/JBoss set of capabilities and applications. This role will help with JBoss EAP configuration through tooling Production, QA and Dev environment builds.
*Part of a small team responsible for migrating to Java, JBoss, Linux platform from Weblogic and Sun Solaris.
*Design and assist in building new capability architecture
Skills:
*Experience with RedHat Enterprise Linux platform (RHEL)
*Thorough understanding of the entire Web Technology Stack
*Experience in Java environments running on JBoss EAP in High Availability configurations.
*Experience with “JON” – JBoss Operations Network
*Experience scaling virtual web infrastructure.
*Excellent scripting skills in bash, python, perl, ruby, or like languages.
*Experience with agile and DevOps methodologies and philosophies.
*Experience with automated provisioning solutions, particularly OpsCode Chef.
*Comfortable in UNIX command line environments.
*Experience with webservices and enterprise level web applications
*Experience with rapid release software development practices (Agile/Scrum)
*Solid understanding of testing components and deliverables within the Software Development Life Cycle (SDLC)
Education: Bachelor’s degree in computer science or equivalent
Guidewire Developer: Washington DC
Required Knowledge, Skills & Experience: Experience with Guidewire application integration or alternatively, 3 or more years experience to include the following – Web developer with strong knowledge of Java, JavaScript, JSP, HTML, XML, and SQL Server 2000/DB2, Spring web services, Industry standard development tools, preferably IntelliJ System Development Methodology, tools, and techniques experience Property and Casualty Insurance industry experience Experience working as a part of an Agile development team. Also Preferred – Experience with Enterprise Service Bus (ESB) technology, preferably Oracle Fusion Middleware.
Essential Functions include: Estimating effort required for each integration point, Designing the overall integration architecture in conjunction with experts in target systems, Designing and coding integration programs including plug-ins, message sinks (and supporting business rules), and programs that call the Guidewire application APIs, Setting up and managing automated build and testing processes (if included in project scope), Resolving issues identified in testing.
C, C++ & MQ Software Engineer Opportunity – Boston
There is an immediate opportunity for software engineer with 5+ years experience in C/C++ and MQ, at Boston location. Some exposure to Java is required. Job function involves MQ setup, configuration work, but primary requirement is experience with C/C++ coding for business logic and use C/C++ MQ libraries to talk to MQ. When sending a resume (as an attachment), please indicate in the email how closely your experience matches the description above and where the gaps are. Also, please indicate your compensation expectations.
Clinical Data Manager – Medical Device Company — San Carlos, CA
There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.
Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices.
HP Extream Architect – LA: 12 month contract opportunity with insurance client
This opportunity requires 12+yrs experience in software architecting with Java platform and content management, including output management. Experience as a Technical Architect and provided advisory services around technical architecture and design. Should be able to design applications which leverage BPM and SOA tools along with CCM Tools. Also required, knowledge of BPM and SOA tools and knowledge of Portals and Content Management systems. Good understanding of Insurance domain, preferred.
Job functions include: Analyze the requirements, technical design and documentation and accordingly raise queries and provide critical inputs; Undertake Solution Design, Technical Architecture and Design of Dialog Applications; Work in Business transformation projects; Handle Pre-Sales and Estimation and Engagement Design for the CCM Practice; Undertake development of new templates; Create new builds and action amendments using HP Exstream; Define Migration Strategy to HP Exstream from other CCM tools like Documerge; Experienced Roadmap visualization and roll out planning and strategizing; Create builds, Supervise Unit Testing and System Testing; Testing and troubleshooting as well as documentation of designs; Train and Groom a team on HP Exstream and bring them to speed; Work with Client and Internal Stakeholders to manage timelines, critical KPIs and deliverables to the client during the course of project; Help in identifying testing procedures and define development standards for performing CCM Application Development on products like Oracle Documaker,Thunderhead, HP Exstream, Papyrus, Doc1 etc.
Clinical Study Manager – CO — requires Medical Device Clinical Study Management Experience, preferably with cardiac valve devices
Project Manager – Albany, NY (full-time, H1B ok)
Job functions: Overall, the project manager oversees a project over the full life cycle, from origination through close out, using a formal project management methodology. He/she takes ownership of the project and provides leadership to the team.
Specific tasks include: develop the project plan, build the project team, develop the schedule using MS Project, maintain the schedule using MS project to track progress, manage resources, manage issues, manage risks, manage changes through a formal change management process, manage user acceptance of deliverables, facilitate meetings, prepare status reports, give presentations to management, and ensure adherence to project management standards and methodologies.
Required skills & Experience: Strong written and verbal communication, interpersonal, and problem solving skills. The project manager must be a team player, who is flexible, has a positive attitude, and is focused on customer service.
84 Months of experience in engaging in project communication including leading regularly scheduled project team meetings, preparing meeting summaries, facilitating meetings to resolve project issues, preparing clear and concise status reports, presenting project status briefings to IT leadership, presenting project status briefings to project steering committees and/or agency executive management. 7.5 10
84months of experience in developing and maintaining schedules in Microsoft Project.
48 months of experience in managing projects using a Project Management Body of Knowledge (PMBOK) based project management methodology containing well defined and documented processes, templates, and guidelines for all project phases, the adherence to which is required and managed by a formal Project Management Office.
48 months of experience in managing COTS software implementation projects and in-house application development (SDLC) projects.
48 months of experience in facilitated elicitation and documentation of business requirements.
24 months of experience in managing projects for New York State agencies.
12 months of experience in managing projects involving multiple entities not belonging to the same organization, e.g, State Agencies, Federal agencies, and Corporations.
Bachelor’s degree.
Project Management Professional Certification.
Net Developer with Oracle – Albany, NY
Daily Tasks will include but not limited to the following:
1. Prepare database scripts for the purpose of creating new Oracle tables, modifying the structure of existing tables, creating indexes, constraints, triggers, etc
2. Maintain .net applications that integrate Microsoft Sharepoint and Excel.
3. Use Microsoft Visual Studio and write code using C# .NET, Java, Ajax, HTML, XML and WCF
4. Use Team Foundation Server as a repository for the source code, for checking code in and out, branching off new versions of the source code, and for tracking project work items
5. Use Crystal Reports to create new and enhance existing reports
6. Develop and maintain .net applications that utilize Microsoft Biztalk to transfer data to and from Oracle/IBM and 5010 billing partners.
7. Create detailed instructions for, and use HP Service Center software to set up change requests for migration of new versions of the application.
8. Monitor and troubleshoot OMH Billing via the SFS bulk load interface.
60 months Demonstrated experience with Oracle: PL SQL coding, stored procedures, packages, indexes, triggers, creating tables, etc, plus a tool to write and test SQL code and manipulate data (such as Toad).
60 months Demonstrated experience using Microsoft Visual Studio 7.5 10
60 months Demonstrated experience programming web based applications in C# or VB .Net in a Multi-Tier environment
6 months Demonstrated Knowledge of the 5010 EDI Transaction set.
60 months Demonstrated experience developing Financial Applications for complex Health related agencies.
6 months Demonstrated Experience developing .Net applications that utilize Microsoft Biztalk to move or translate data in near real time.
6 months Demonstrated Experience integrating custom billing applications into the SFS bulkload process.
6 months Demonstrated Experience developing .Net applications that integrate Microsoft .net, excel, and sharepoint.
Requested Qualifications Must Always Total 80 Points
Mainframe Developer – Albany, NY (full-time, H1b ok)
Responsibilities: Expert analysis, support, development, reengineering, and implementation of multiple business applications. Support is required for specific programming languages (COBOL, SQL, and Java), for specific DBMS’ (DB2 for z/OS, DB2 for LUW, IDMS), and using specific technologies (MQ Series, CICS, Sort, JCL, VSAM, AQT, DBI performance tools, ERwin, TSO/ISPF, Data Studio, z/OS, AIX).
• Provide performance analysis and tuning, troubleshooting, capacity planning, benchmark design, and job scheduling policies.
• Implement backup and recovery strategies, and phased implementation/conversion planning for new and converted applications.
• Design methodologies for data synchronization from operational data stores to a data warehouse across multiple database platforms and varied DBMS’.
• Planning, interfacing, and usage between application databases, data warehouse, Cognos, Identity Systems, Vality, Finalist, and eCommerce.
• Act as liaison between Data Management, business customers, and application development staff to ensure that recommended performance considerations are included in reviews, designs, development, and implementation of applications.
• Proven experience in utilizing database structures, application methodologies, and coding techniques resulting in cost efficient and timely solutions to the strategic business requirements.
• Serve as a subject matter expert on production DTF application systems (e.g., Returns Processing, Taxpayer Identification for fraud prevention, Imaging, reciprocity applications between Federal and State agencies (SWOP, FROP, LOP, IFTA), electronic filing, Withholding Tax).
84 months of DB2 for z/OS programming experience using COBOL and/or Java, including logical design, database navigation, analysis, writing application specifications, testing, and documentation
At least 84 months of programming experience using COBOL and/or Java, including database navigation, analysis, writing application specifications, testing, and documentation with database management systems other than DB2 for z/OS.
At least 24 months of DB2 for LUW programming experience using COBOL and/or Java, including database navigation, analysis, writing application specifications, testing, and documentation.
At least 24 months of IDMS programming experience using COBOL and/or Java, including database navigation, analysis, writing application specifications, testing, and documentation.
At least 84 months of database administration experience (including database performance analysis and tuning, capacity planning, SQL tuning, buffering, physical design, data storage, and interfaces) on DB2.
Also required, minimum 24 months experience with performance analysis and tuning on large complex applications, minimum 24 months experience with performance analysis and tuning on large complex applications utilizing IDMS, minimum 84 months experience working in Federal, State, or City Taxation institution(s) as a lead technical expert on large, complex applications and/or as a lead DBA in support of such applications, minimum 84 months experience in developing, and/or tuning 24/7 transactional environments for high-volume/high-risk applications that contain WEB interfaces, CICS (APS) components, and batch processing.
Jobs – January, 2013
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on January 4, 2013
Guidewire ClaimCenter Professional - (location – Washington DC).
This is a one year contract opportunity.
SOA Engineer Lead Role – Tampa, FL – 1 year duration
There is an immediate opening at Tampa, Florida location for SOA Engineer for 1 year duration contract work.
Skills required: Very strong knowledge in WebLogic 10.x/11g and FMW space, Strong knowledge Oracle SOA10g/11g & OSB11g implementation/administration, Experience with all out of box technology adapters (Apps, DB, MQ, JMS, File, FTP, etc.) and configuration, Experience with Oracle OAS10g, BPEL, OHS, OWSM, SSL strategies, Linux, Unix, Windows Server, AS400, z/OS, Oracle OEM11g/12c, IBM Tivoli, Subversion, SQL, Visio, Oracle SOA/ESB development skills a plus but not required, Scripting knowledge (WLST, ANT), JVM monitoring/tuning experience, Performance monitoring and tuning, Strong communication skills.
Job responsibilities include: Architecture planning and design for all related components, Evaluate project proposals and estimated related labor to implement, Installation and configuration for environment builds including post build expansion, Product patching and analysis for implementation, Capacity planning and scaling analysis for all components, Create and maintain documentation as needed for future reference, support turnover, etc., Present topics of interest for team knowledge and review related to ongoing initiatives, Participate in knowledge transfer for level 1/2 support teams, Performance monitoring and identification of related issues, Manage engineering service requests and defects, Support code migration, automation and troubleshooting, Engage with other IT tech teams and request systems for troubleshooting or infrastructure dependencies related to project task completion, Provide guidance for Level1/2 teams as relates to their assigned tasks, Initiate, communicate and drive production changes via formal change management system, Take ownership of assignments and drive them to conclusion, Initiate vendor support requests and keep momentum for conclusion, Implement monitoring solutions as needed for existing or new components, Implement automation solutions for repetitive tasks where appropriate, Participate in 7×24 on-call rotation support for production.
Oracle SOA Architect – Herndon, VA, – 1 year Duration
There is an immediate opportunity for Oracle SOA Architect at Herndon, VA for 1 year duration contract job.
Skills & experience required: Min 10 years of experience in Software Design/Development, Project experience in designing and implementing Oracle SOA suite components, Experience in the design/ implementation of technology infrastructure and architecture blueprint including Oracle Fusion Middleware, Must have experience as an SOA Architect /Tech Lead in delivering at least two SOA Enterprise-level Projects including at least one involving legacy mainframe systems, Hands on experience in SOA analysis/planning, Service Modeling, Business Process design, SOA Composition, SOA Governance etc., Strong Java/JEE development experience, specifically in regards to deploying applications, leveraging AIA patterns and experience in architecting SOA-based solutions, Proven project experience with hands-on development and configuration experience in Oracle JDeveloper 11g with strong BPEL design/development skills, Technical know-how on and hands on experience in designing a SOA governance framework using Oracle SOA products, Excellent written and verbal communications skills, Experience with UML. Knowledge of design patterns.
Required Tech skills: OSB (Oracle Service Bus ), Oracle Mediator, BPEL Process Manager, Oracle BPM(Business Process Manager), Oracle CEP (Complex Event Processing), Oracle Policy Manager, Metadata Service Repository, Oracle Business Activity Monitoring, OEM (Oracle Enterprise Manager), Oracle Adapters, Oracle Business Rules, Oracle User Messaging Service, JDeveloper , Java, J2EE, Web Services , SOA, REST , XML /XPath / XQuery / XSLT, Any recent versions of Oracle Database.
Seeburger Architect – Hartford, CT, 1 year duration
There is an immediate opportunity for Seeburger Architect for 1 year duration at Hartford, CT location.
Skills & requirements include: Should have architecture and design experience, Should know the pros and cons of various B2B products vs Seeburger BIS 6 and BIC 6, Should have work experience in BIS6 and migration, Should be well aware of communication protocols and transaction standards, Should have worked in Business process implementation and testing using BIS6 process designer, TP setup and mapping experience using BIC6 Mapping designer, Should have good communication skills, Should have onsite –offshore and SDLC work experience.
Analog Design Engineer – Sunnyvale, CA
A Contract Engineering company located in Sunnyvale, CA has an immediate part-time contract opportunity for Analog Design Engineer, that is likely to become permanent in 3-6 months. Minimum 10 years of experience with analog circuit design, including amplifiers, ADCs, power supplies, and sensor signal conditioning is required. Also required, experience with digital design and ability to work with digital engineers to develop successful integrated products. Experience with signal integrity and/or RF design a plus.
The person must work well on a team, have good communication skills, and be able to adjust quickly in a fast paced environment where many designs are done simultaneously. This is a challenging and rewarding opportunity for the right person.
Clinical Data Manager – Redwood City, CA
There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.
Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices.
Sales Rep – Los Angeles, CA
This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. This position is located in Los Angeles, CA.
Jobs – December, 2012
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on December 5, 2012
For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa.
Analog Design Engineer – San Jose, CA
A Contract Engineering company located in Sunnyvale, CA has an immediate contract opportunity for Analog Design Engineer, that is likely to become permanent in 3-6 months. Minimum 10 years of experience with analog circuit design, including amplifiers, ADCs, power supplies, and sensor signal conditioning is required. Also required, experience with digital design and ability to work with digital engineers to develop successful integrated products. Experience with signal integrity and/or RF design a plus.
The person must work well on a team, have good communication skills, and be able to adjust quickly in a fast paced environment where many designs are done simultaneously. This is a challenging and rewarding opportunity for the right person.
Clinical Data Manager – Redwood City, CA
There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.
Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices (510K, class III devices, PMA).
Sales Rep Opportunity – Orange County, Los Angeles, CA
This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. Compensation will include commission, bonuses, and stock options during the first 60 days and then will include cash based compensation. This position is located in Los Angeles, Orange County, CA.
JOBS – November, 2012
Posted by Darshana V. Nadkarni, Ph.D. in Biotech, Pharma & Medical Device News, JOB OPENINGS on November 21, 2012
For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa. More opportunities will be added soon.
Clinical Data Manager – Redwood City, CA
There is an immediate opening for Clinical Data Manager for San Carlos, CA based medical device company. Responsibilities include, design, develop and enhance clinical databases and data reports and perform validation of databases and reports to ensure data accuracy, completeness and integrity of data entry, discrepancy database management, study documentation and data auditing. Job functions include, participating and providing support for data management activities, investigator meetings, DSMB meetings and regulatory submissions, assisting study team with the preparation of data collection forms and charts for the reporting of research data, supporting international and FDA regulations and company goals, policies and procedures, and complying with Quality System.
Requirements include, knowledge in regulatory requirements, FDA, ICH, GCP etc. guidance, experience using Commercial Off the Shelf Clinical Data Management and/or Electronic Data Capture products (e.g. Clindex, Oracle Clinical, Phase Forward, eTrials, etc.) is required. Experience using relational databases (e.g. MS SQL Server, MS Access, or Oracle) is a plus. Also required, a Bachelor’s degree in related field with minimum 3 years experience in clinical data management supporting clinical trials, including experience in regulatory submission of drugs or medical devices (510K, class III devices, PMA).
Sales Rep Opportunity – Orange County, Los Angeles, CA
This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. Compensation will include commission, bonuses, and stock options during the first 60 days and then will include cash based compensation. This position is located in Los Angeles, Orange County, CA.
JOBS – October, 2012
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on October 3, 2012
For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa. More opportunities will be added soon.
Sales Rep Opportunity – Orange County, Los Angeles, CA
This position will play a visible role in drug rep industry, by developing critical relationships, primarily with doctors of many disciplines to share the availability of breakthrough pharmaceutical grade pain management option that would diminish pain, aid in sleep, and enhance quality of life as a holistic alternative to addictive and sometimes life threatening drugs. Specific responsibilities will include, provide field based scientific exchange and communication regarding the product, broad interdisciplinary background and proven ability to establish relationships with doctors across variety of disciplines, tenacity and drive to reach out to new doctors, and ability to work the referrals, and to network and partner with medical practitioners. Requirements include, pharma or medical industry sales background, strong sales success track record, consummate professionalism including understanding of sensitivity of subject along with ability to deal warmly with high powered, industry-leading medical professionals, strong entrepreneurial spirit and passion for the vision of managing pain with a holistic alternative. Compensation will include commission, bonuses, and stock options during the first 60 days and then will include cash based compensation. This position is located in Los Angeles, Orange County, CA.
Software Engineer – San Francisco, CA
Company located in San Francisco has an immediate opening for Software Engineer. Responsibilities include 100% hands on coding including all levels of code from database interaction and core business logic up through html/css/javascript, and design and develop and deploy the server side of all user facing features including rich web experience to APIs. The company is working on disruptive technology that will have a broad impact. Requirements include 5+ years software engineering experience including a good sense of software architecture, and solid web application development experience with any of the following: ruby, python, javascript, objective c, SQL, Postgres. Prior programming experience, open source contributions, experience scaling web services, and experience with HIPPA and IEC 16304, ISO13485, or ISO60601 would be a great plus.
Front-End Developer Software Engineer – San Francisco, CA
There is an immediate job opening in a San Francisco company for software engineer who can help drive services from a front-end, design driven perspective. Requirements include, strong knowledge and experience with HTML, CSS, and JavaScript, understanding of principles of design, user experience, and user interface, understanding of principles of object-oriented development, ability to navigate into Photoshop layers to export slices and make sprites, and ability to write compliant code.
Software Engineer – Sunnyvale, CA
A start up in a valuable space with a unique perspective to it, founded by Google Alumni and and other domain experts in the field are looking to bring in someone who can lead the technical side of the startup. BS in Computer Science is required. Desired skills include Php, MySQL, javascript, html5, phtoshop, Ruby on Rail, java, mongoDB or any other database skills. Must be passionate about programming and absolutely must be a self-starter.
Electro-Mechanical Engineer – San Francisco, CA
San Francisco based company has an immediate opening for Electro-Mechanical Engineer with experience in designing products, including machined parts, sheet metal, injection-molded plastic, and electro-mechanical assemblies. This position will lead concept development through volume manufacturing, working closely with external industrial design partner to design products that incorporate thermal analysis, optical components, circuit boards, electronic components and mechanical structures. Responsibility also includes developing assembly processes including fixture design, equipment selection, material selection, and process documentation. BS in Engineering and 5+ years experience in designing and analysis of electro-mechanical systems including diverse electronics, components, integration, sensors, filters, and actuators is required. Also required, 5+ years experience in related mechanical design, experience with injection molded parts and circuit boards integrated for medical devices or consumer products. Experience with calculating draft angles, tolerance stickups, and biocompatible surface coatings, required. Also required, experience with CAD design using Solidworks, Pro-E (or (or extensive experience in similar CAD packages, such as AutoCAD, experience with thermal analysis (e.g. thermo-electric coolers) and pressure flow analysis, and experience with microelectronic assembly techniques and design for manufacturability. Knowledge of manufacturing processes and injection-molding tooling and sourcing components from vendors is required. Experience creating engineering change documentation for new product releases and existing product improvements required specifically for medical devices. Experience with OrCAD or other circuit design software and experience with laser and opto-electronics systems would be a major plus. injection molded plastics thermal, structural, manufacturability and serviceability.
JOBS – July, 2012
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on July 4, 2012
For the opportunities below, please send resume to wd_darshana at hotmail dot com. Candidates must be based in the USA and have valid US work visa.
Software Engineer – Sunnyvale, CA
A start up in a valuable space with a unique perspective to it, founded by Google Alumni and and other domain experts in the field are looking to bring in someone who can lead the technical side of the startup. BS in Computer Science is required. Desired skills include Php, MySQL, javascript, html5, phtoshop, Ruby on Rail, java, mongoDB or any other database skills. Must be passionate about programming and absolutely must be a self-starter.
Analog Design Engineer – Sunnyvale, CA
A Contract Engineering company located in Sunnyvale, CA has an immediate permanent, full time opportunity for Analog Design Engineer. Minimum 10 years of experience with analog circuit design, including amplifiers, ADCs, power supplies, and sensor signal conditioning is required. Also required, experience with digital design and ability to work with digital engineers to develop successful integrated products. Experience with signal integrity and/or RF design a plus.
The person must work well on a team, have good communication skills, and be able to adjust quickly in a fast paced environment where many designs are done simultaneously. This is a challenging and rewarding opportunity for the right person.
Product Manager for Medical Services — San Francisco, CA
Healthcare IT company located in San Francisco has an immediate opening for Product Manager of Medical Services. This position is responsible for leading the development and execution of various services the company provides to medical professionals, patients, and consumers who purchase the device, including interpretive algorithms, human over-read services etc. Job responsibilities include, developing the overall plan for services to be provided in conjunction with the product, including interpretive algorithms and human over-read services, develop the strategic approach to these services as well as execute against them, including the market sizing, competitive analysis, and pricing related to new services, understand customer needs and drive an optimized user experience for services, gather feedback and integrate as needed into current and future services provided, work closely with engineering to develop the integration between services, hardware, and the web, and negotiate with potential partners for providing services. BA/BS in healthcare or technology is required. Also required, minimum 5 years experience in business development, product management, or strategic planning, preferably with medical device and hardware/technology products as well as consumer health products. Experience working in the electrocardiogram/ cardiology sector and knowledge of ECG related algorithms and humans over-read services is essential. Advanced medical/healthcare degree preferred. Experience in managing small projects a huge plus.
Medical Device Product Manager — San Francisco, CA
Innovative healthcare IT startup company located in San Francisco, CA has an immediate opening for Product Manager. Responsibilities include, leading the vision and execution of device product hardware in conjunction with product development and marketing teams. Company’s vision is to create iconic devices that as a portfolio are uniquely recognizable. This responsibility extends to three new products already in early stages of design. Job functions include, managing the entire product line life-cycle from market sizing to tactical activities company’s medical device products, specifying market requirements for current and future products by conducting market research supported by on-going visits to customers and non-customers, work closely with inernal development teams and outside product design firms to build the products. Responsibilities also include, developing and implementing go-to-market plans, working with all teams to execute, analyzing potential partner relationships for the devices, and managing the overall product development process, including maintaining feature improvement roadmaps. BS in Mechanical or Electrical Engineering is required. Also required 5+ years of software marketing/product management experience, preferably in consumer products.
High Volume Manufacturing Automation Engineer – San Jose, CA
There is an immediate opportunity for Manufacturing Automation Engineer with a drug delivery company, working on cutting edge technology, to lead lean manufacturing for high volume manufacturing process. Potential candidate should be able to automate manufacturing processes and develop, evaluate, and improve manufacturing methods using mechanical assembly and automation techniques, implement tooling and automation requirements to ensure efficient production methods, and assemble components. Experience with motors, sensors, and knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards will be required to implement state of the art, sterile automated manufacturing process. This is a unique opportunity to work with a veteran leader of several prior successes, and will include stock options.
Ultra Low Power Analog Design Engineer – San Jose, CA
There is an opening in CA & TX for ultra low power analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise. Compensation will be commensurate with experience, in addition to the stock options. The stock options could make this highly attractive opportunity. The position requires 10+ years of experience with medical device low power analog circuit design and embedded design experience.
Sterile Pharma Quality Engineer – San Jose, CA
Drug delivery company has an immediate opening for Senior Quality Engineer with 10+ years pharmaceutical industry experience in sterile manufacturing and process qualifications for injectible drugs. Experience in documentation and batch process and automation quality systems setup and management experience is required. Qualifications should include BS in Chemical Engineer, Mechanical Engineering or related. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
Machinist – San Antonio, TX
Innovative medical device/ biotech in Texas has an immediate opening for Machinist. The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup. (Stock options could make this a once in a lifetime kind of an opportunity). The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems. The candidate must be familiar with fabricating small parts or tooling on a lathe and mill. Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.
JOBS – June, 2012
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on June 7, 2012
For the opportunities below, please send resume to wd_darshana at hotmail dot com.
Junior Software Embedded Engineer – Sunnyvale, CA
There is an immediate opportunity for Junior Embedded Engineer in $60-$80K salary range with a reputed contract engineering company, located inSunnyvale,CA. This position requires an understanding of both hardware and software and how each can influence the other at all levels of the design process. This opportunity offers a chance to work on a wide range of fun and interesting projects and an opportunity to work with and be mentored by a world class team of staff and consultants. Requirements include MSEE + 1-2 years experience or BSEE + 2-3 years experience, keen interested in embedded systems and some experience with a number of current processor architectures, e.g. PIC, MSP430, ARM. Also required, an ability to program embedded systems in C, C++ or other languages, knowledge of assembly language, knowledge of test equipment such as oscilloscopes, logic analyzers etc and how to use them, experience with schematic capture, along with the ability to build simple prototype electronic circuits, and ability and skill to interpret customer requirements into design ideas and the knowledge and confidence to take those forward into a working solution with the assistance of other members of staff.
Sterile Pharma Quality Engineer – San Jose, CA
Drug delivery company has an immediate opening for Senior Quality Engineer with 10+ years pharmaceutical industry experience in sterile manufacturing and process qualifications for injectible drugs. Experience in documentation and batch process and automation quality systems setup and management experience is required. Qualifications should include BS in Chemical Engineer, Mechanical Engineering or related. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
Injection Molding Machine Building & Manufacturing Engineer – San Jose, CA
The ideal candidate for this job will be an expert in injection molding with 10+ years of deep experience. Experience working with suppliers is not enough. Experience with tool design and mold machine building is required. Also required, mold design, AND operating, and fabricating of injection molding machines. Working knowledge of design/development of manufacturing systems with emphasis on new molds and molding processes, creating and understanding mold flow analysis and ability to implement installations or modifications of new equipment and/or machinery to support the injection molding processes is required. Hands on experience in the tooling part of plastic injection molding, taking apart and adjusting molds on a daily basis will be called upon. Experience in Autocad and SolidWorks and BS in Mechanical Engineering is required. Experience in vacuum forming, a huge plus. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
PS – this is a very specialized opportunity and requires mold machine building experience to work on the first prototype that the CEO has built for very customized medical application.
Machinist – San Antonio, TX
Innovative medical device/ biotech in Texas has an immediate opening for Machinist. The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup. (Stock options could make this a once in a lifetime kind of an opportunity). The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems. The candidate must be familiar with fabricating small parts or tooling on a lathe and mill. Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.
Pharmacologist with In-Vivo Experience: San Antonio, TX
A dynamic company, found by a veteran leader of several successful startups, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential. The applicant must have a BS with a minimum of 8 years (or MS with at least 6 years) of hands-on laboratory experience. The individual is expected to have a breadth of experience in in-vitro and in-vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.
The applicant will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the applicant will set up and run a variety of routine in vitro research paradigms as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The applicant will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects. The position requires a strong background in cell biology, chemistry, biochemistry, immunology, physiology or a related area. Position, salary and benefits are commensurate with experience.
High Volume Manufacturing Automation Engineer – San Jose, CA
For the opportunity below, please send resume to wd_darshana@hotmail.com. Candidates must be based in the USA and have valid US work visa.
There is an immediate opportunity for Manufacturing Automation Engineer with a drug delivery company, working on cutting edge technology, to lead lean manufacturing for high volume manufacturing process. Potential candidate should be able to automate manufacturing processes and develop, evaluate, and improve manufacturing methods using mechanical assembly and automation techniques, implement tooling and automation requirements to ensure efficient production methods, and assemble components. Experience with motors, sensors, and knowledge of product design, materials and parts, fabrication processes, tooling and production equipment capabilities, assembly methods, and quality control standards will be required to implement state of the art, sterile automated manufacturing process. This is a unique opportunity to work with a veteran leader of several prior successes, and will include stock options.
Ultra Low Power Analog Design Engineer – San Jose, CA
There is an opening in CA & TX for ultra low power analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise. Compensation will be commensurate with experience, in addition to the stock options. The stock options could make this highly attractive opportunity. The position requires 10+ years of experience with medical device low power analog circuit design and embedded design experience.
JOBS – May, 2012
Posted by Darshana V. Nadkarni, Ph.D. in JOB OPENINGS on May 1, 2012
For the opportunities below, please send resume to wd_darshana at hotmail dot com.
IT Project Manager (Contract Opportunity) – Bay Area, CA
There is contract opportunity for IT Project Manager with a Biotech company. The start date for the contract is July, 1 and the project is expected to last 9-12 months. The candidate is expected to have 10-15 years of experience in Project Management. Job responsibilities include, plan, execute, and finalize projects according to strict deadlines and within budget, acquiring resources and coordinate the efforts of team members and third-party contractors or consultants in order to deliver projects according to plan. Responsibilities also include, define project scope, goals and deliverables to develop full-scale project plans, liaise with project stakeholders on an ongoing basis, supervise project team members, identify and resolve issues and conflicts within the project team, proactively manage changes in project scope, and identify potential crises. The immediate projects include implementing company laptop encryption system, learning management system validation, and completion of proof of concept deliverables pertaining to data mapping and data migration between HR Master and AWR and Exterro.
Junior Software Embedded Engineer – Sunnyvale, CA
There is an immediate opportunity for Junior Embedded Engineer in $60-$80K salary range with a reputed contract engineering company, located inSunnyvale,CA. This position requires an understanding of both hardware and software and how each can influence the other at all levels of the design process. This opportunity offers a chance to work on a wide range of fun and interesting projects and an opportunity to work with and be mentored by a world class team of staff and consultants. Requirements include MSEE + 1-2 years experience or BSEE + 2-3 years experience, keen interested in embedded systems and some experience with a number of current processor architectures, e.g. PIC, MSP430, ARM. Also required, an ability to program embedded systems in C, C++ or other languages, knowledge of assembly language, knowledge of test equipment such as oscilloscopes, logic analyzers etc and how to use them, experience with schematic capture, along with the ability to build simple prototype electronic circuits, and ability and skill to interpret customer requirements into design ideas and the knowledge and confidence to take those forward into a working solution with the assistance of other members of staff.
Quality Engineer – San Jose, CA
Drug delivery company has an immediate opening for Senior Quality Engineer with 10+ years pharmaceutical industry experience in sterile manufacturing and process qualifications for injectible drugs. Experience in documentation and batch process and automation quality systems setup and management experience is required. Qualifications should include BS in Chemical Engineer, Mechanical Engineering or related. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
Injection Molding Machine Building & Manufacturing Engineer – San Jose, CA
The ideal candidate for this job will be an expert in injection molding with 10+ years of deep experience. Experience working with suppliers is not enough. Experience with tool design and mold machine building is required. Also required, mold design, AND operating, and fabricating of injection molding machines. Working knowledge of design/development of manufacturing systems with emphasis on new molds and molding processes, creating and understanding mold flow analysis and ability to implement installations or modifications of new equipment and/or machinery to support the injection molding processes is required. Hands on experience in the tooling part of plastic injection molding, taking apart and adjusting molds on a daily basis will be called upon. Experience in Autocad and SolidWorks and BS in Mechanical Engineering is required. Experience in vacuum forming, a huge plus. This is a grounds level opportunity to work on game changing technology with solid IP and secure funding, under the leadership veteran leader with several successful companies. Compensation will be commensurate with experience and will include stock options, with great potential.
PS – this is a very specialized opportunity and requires mold machine building experience to work on the first prototype that the CEO has built for very customized medical application.
Clinical Project Manager
The position will support US and OUS clinical trials in a cross-functional role to support the clinical study team.
Essential functions include manage clinical trial operations with a specific focus on European feasibility investigations, establish and maintain study master files, work with sites to prepare submissions, secure study documentation, and negotiate contracts, manage case report form data and monitoring activities, develop and refine clinical trial procedures, create and prepare materials for Investigator, Coordinator, and DSMB meetings, prepare Case Report Forms, support field clinical staff with significant involvement in site assessments, monitoring activities, site audits, and site closures as needed, write and file Adverse Event reports, annual reports, and other communications with Ethics Committees, Competent Authorities, and Institutional Review Boards, perform clinical data entry, report generation, work with sites to resolve data queries, support investigators with publication activities, as needed, provide regulatory support for US and OUS clinical submissions, interface with Regulatory Affairs department to provide support for ongoing regulatory activities, provide support for new and ongoing regulatory submissions, provide support for Product Development and Operations, development, writing of Manuals and training materials, and participate in clinical validation and product development verification activities
BS in life sciences or equivalent with a minimum of 5 years related experience in supporting medical device clinical trials is required. Experience working directly with US and EU sites and working with clinical data and database experience, strongly desired. Familiarity with literature searches, experience monitoring sites, and scientific writing skills, preferred. About 10% travel will be required.
Machinist – San Antonio, TX
Innovative medical device/ biotech in Texas has an immediate opening for Machinist. The company is found by a veteran leader with number of prior successes and this is an opportunity to contribute at grounds level, in a promising startup. (Stock options could make this a once in a lifetime kind of an opportunity). The mechanical engineer/ technician will work with other engineers to develop innovative drug delivery systems. The candidate must be familiar with fabricating small parts or tooling on a lathe and mill. Successful candidate will have combination of mechanical and electrical skills. At least 5 years experience in medical device industry is required.
Pharmacologist with In-Vivo Experience: San Antonio, TX
A dynamic company, found by a veteran leader of several successful startups, involved in the development of drug-device combination products for treating chronic diseases, has an opening for a Biologist. This is once in a lifetime kind of an opportunity to work on exciting technology with game changing potential. The applicant must have a BS with a minimum of 8 years (or MS with at least 6 years) of hands-on laboratory experience. The individual is expected to have a breadth of experience in in-vitro and in-vivo biological research supporting various drug/ device development programs across multiple therapeutic areas including CNS, oncology, cardiovascular and metabolic diseases.
The applicant will support and work with external institutions including CROs and academic institutions especially for conducting in vivo studies in small as well as large animals. Additionally the applicant will set up and run a variety of routine in vitro research paradigms as needed such as isolated tissue and cell-based assays as well as quantitative assays for small molecules, peptides and proteins using techniques such as FTIR, HPLC, and immunoassay. The applicant will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects. The position requires a strong background in cell biology, chemistry, biochemistry, immunology, physiology or a related area. Position, salary and benefits are commensurate with experience.
Ultra Low Power Analog Design Engineer – San Jose, CA
There is an opening in CA & TX for ultra low power analog design engineer for a company found by a veteran leader of several successful companies. This is an exciting opportunity to work on cutting edge technology, with a great promise. Compensation will be commensurate with experience, in addition to the stock options. The stock options could make this highly attractive opportunity. The position requires 6+ years of experience with medical device low power analog circuit design and embedded design experience.
My colleague is working on the opportunities below. If you have an interest, please mention the opportunity in the subject line, with your name and send your resume and I will forward it to him.
Director of Clinical – San Jose, CA
VP of RA/QA – Redwood City, CA
Senior Manager of RA/QA – San Francisco, Ca
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