Posts Tagged Quality Engineer
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. Please note: All below opportunities (except one for post doc) require several years of industry experience and are only for local candidates, with valid US work visa. Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled. Also, I am awaiting job descriptions for following positions & will be posting the details soon – Quality Assurance Engineer, Mechanical Engineer, Senior ME Technician and Software QA Tester. Immediate need in many of the opportunities below, is experience in the area of medical injection molding. Leads appreciated. (BTW – I love live entertainment and if your lead results in a hire, if reminded, I will love to invite you and cover for your ticket, to accompany me to the theater for one of the upcoming plays of your choice at one of South Bay area theaters).
R&D Technician – San Jose, CA
There is an immediate opening for a Medical Device Senior Technician in an early stage company, located in San Jose, CA, developing a novel approach for the oral delivery of large molecules.
Responsibilities: Perform experimental device component fabrication, device assembly; device testing and analysis, maintenance and troubleshooting on manufacturing equipment and process, Develop fixtures for testing or manufacturing, and Compile data on device testing.
Requirements: 5+ years work experience in an industrial or laboratory environment; experience in medical device or pharmaceutical operation, with test equipment including instron, burst, weight, pressure, and force test equipment and with basic chemistry laboratory processes including measuring, mixing solutions, chemical storage, and laboratory safety.
Also required: Demonstrated mechanical skills, Ability to read and follow written instructions, Ability to interpret engineering drawings, Familiarity with plastic manufacturing processes including molding, forming, and bonding, Familiarity with principles of machine operation, machine control systems, pneumatics, and motors, Computer skills including Word, Excel, Outlook, Ability to operate independently and function as a team member, Good written and verbal communications skills., Familiarity with principles of GMP and/or GLP operations.
Territory Account Manager for Medical Injection Molding Operations – Santa Cruz, CA
Responsibilities: Initiate and evolve customer relationships for the purpose of securing production business for company’s medical injection molding and assembly operations, located in Minnesota and California. Activities include researching and calling potential identified customer opportunities and promoting capabilities and technology through presentations and meetings. Interaction with internal engineering group to facilitate completion of quoting opportunities on a timely basis. Presentation of quotes and ultimately the closing of new business.
Job Functions: Work to exceed individual/company annual sales goals; Participate in weekly sales meetings; Provide weekly sales activity reports; Sales pipeline reporting is required for the sales director, for review and discussion at the monthly managers’ financial review meeting; Work industry trade shows and follow up on leads, as required.
Major areas of accountability: Initiate and Evolve Customer Relationships to Meet Annual Sales Objectives – 75%; Account Maintenance – 20%; Monthly Reporting – 5%.
Financial Responsibility: Expense management.
Requirements: Bachelor’s Degree; Basic knowledge of molding and assembly for medical device manufacturing; Ability to understand technical drawings and related requirement information; Minimum of 2 years previous technical selling experience required.
IP Legal Secretary/ Paralegal – San Rafael, CA
Requirements : Strong docket filing experience; Thorough knowledge of patent & trademark prosecution process; Experience with Electronic Filing with USPTO and Pair; Ability to type at least 60 words per minute; Knowledge of time slips program to facilitate accounting & billing functions; Experience preparing time reports, expense reports, client bills & conflict checking forms; & Familiarity with legal terminology. Absolutely required, 5+ years experience with patents and dockets; 5+ years experience working as legal secretary.
Responsibilities: Provide secretarial & administrative support; Assist with preparation & filing with USPTO and of foreign patent & trademark applications; Generate transmittals & formal USPTO documents; Handle foreign patent & trademark prosecution matters including PCT & foreign prosecution forms; Monitor patent prosecution docket; Prepare & file maintenance fees, assignments, missing parts & IDSs; Proofread & redline work for accuracy of copy, format, grammar, punctuation, and syntax; Type & edit computer system legal & other documents (including memoranda, bills, timesheets & project work) from handwritten or typed materials; Copy, distribute, send by courier or express service, File & otherwise handle completed work; Receive, screen & transmit telephone calls, conference calls & messages; Handle incoming & outgoing mail; Set up & maintain files. Should work independently, take initiative, set priorities & see projects through completion; Work in a team setting.
Software Quality Assurance (SQA) Engineer – San Francisco, CA
A software company that provides innovative, modular, scalable and world class solutions by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is scaling, in pre-funding stage. The company is expanding core engineering and product development team & looking for high caliber, senior, Quality Assurance Test Engineers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.
Responsibilities: Acquire in-depth understanding of the company’s products to ensure high quality of products; Support the development of workarounds, testing, necessary documentation (including investigation and resolution of issues; Assist in coordinating delivery management tasks; Track requirements and software release management for clients; Be first escalation point for supporting company’s customers.
Requirements: Must have strong client support & project management background. Must have 4-6 years of implementation & post production support experience for enterprise applications; 3-4 years of functionality, testing, bug tracking, writing test cases experience; strong communication skills; demonstrable hands-on experience with quality management tools; technical skills in SQL, HTML based documentation. Highly preferred: skills in developing and managing on-line help content.
Location: San FranciscoBay Area. Telecommuting is okay but will need to attend client team meetings – so must be in driving distance. Duration: 6-12 months, full to part-time, 1099, corp to corp, contract to hire. No visa sponsorships.
Post-Doc ———- San Jose, CA
A medical device company has a post-doc position. Requires PhD in Material Science, BioEngineering, BioChemistry or related areas, ideally from a top notch school. Must have excellent references. Send resume as an attachment with brief description of the academic experience and projects, in the body of the email.
Injection Molding Tooling Engineer – Santa Cruz, CA
A contract manufacturing company has an immediate need for Injection Molding Tooling Engineer. This position will lead and own the design, development, and procurement of all new injection mold tooling, insert mold tooling and fixtures and oversees all design changes, modifications and repairs to new and existing tooling. They will be part of the Operations team on all new product launches.
Responsibilities include, Develop primary design concepts for tooling working in conjunction with our Customers Engineering Staff and the Director of Engineering; Establishes and maintains relationships with outside tooling sources; Directly manage the construction of all new tooling with domestic and off shore tooling suppliers; Directly manage the construction of all new gauges and fixtures needed with new tools; and Communicate with supplier and customer on a technical level. Responsibilities include the establishment of technical and quality requirements for programs; Design modifications to tools and fixtures using Solidworks, or Pro E; Responsible for tracking tooling budget to quote; Work directly with the Program Managers to ensure customer and supplier terms are followed; Review of piece part prints, tolerances and GD&T and communicate requirements to Quality; Attend APQP meetings and take part in PFMEA, Control Plan and Line Documentation meetings; Direct efforts of outside tool and die shops this include selecting suppliers and reviewing and approving designs while working in conjunction with the Program Manager; Insures deliveries by outside vendors that meet the program requirements and meet established budgets for tooling procurement; Maintain CAD files associated with tooling in compliance with associated internal document control procedures; Takes part in mold start up trials at the tool maker, internally and at offsite locations; Tracks timing of tools using MS Project; Ability to tear down and maintain molds when needed.
Requirements include, Ability to manage multiple tooling sources simultaneously; An understanding of injection molding processing; Is knowledgeable in automation equipment for labor reduction efforts; Creates validation protocols; Understands and knowledge of IQ,OQ,PQ validation processes; Must be able to travel to suppliers and customers domestically, travel to tooling sources in Asia may be required. Minimum of 10 years experience managing injection mold construction and 5 years Solid Works/ ProE Experience is required. Also must have direct experience with managing tool construction. Medical thermoplastic injection molding experience is a huge plus.
Patent Attorney – Sunnyvale, CA
Innovative medical device company with a broad line of product portfolio, has an opening for Senior Patent Attorney for VP level position. Must have 15+ years of medical device and biotech patent prosecution experience in a law firm.
Manufacturing Manager – Santa Cruz, CA
Job Functions & Responsibilities: This position will be responsible for managing production operations to ensure business objectives are achieved at the lowest cost consistent with customer delivery and quality requirements. Responsibilities include: Manufacturing scheduling and staffing; Production methods and standards; In-process product quality; Materials responsibilities including procurement and inventory management; Safety policies and procedures; Hourly employee development, performance management and relations; Continuous improvement and Lean Manufacturing Leadership and implementation; Budget management and cost containment.
Requirements: Knowledge of Manufacturing concepts and principles; Experience in Lean Manufacturing, Process management/statistical process control, Production layout/design/method, Manufacturing equipment management and knowledge of Business and office system software. Also required, experience in Capacity planning; Scheduling/MRP; Budget management; Team development of both hourly and salaried direct reports; Problem analysis/solving; Managing internal and external relationships. Bachelors degree or equivalent experience required. Also required, Medical/Cleanroom/Assembly experience; Experience managing a 24/7 operation; Ten years manufacturing experience; Management experience; Experience in the Injection Molding/Plastics industry.
Accountability measures include, Quality, Safety, Productivity, Utilization, Service, Deliver, Cost efficiency and continuous improvement, and Employee development and retention.
Software Developers – SF Bay Area (contract, part-time)
Big data and machines are revolutionizing the way we operate. A software company that provides innovative, modular, scalable and world class solutions, in this industrial-internet paradigm, by leveraging state of the art sensor technologies, cloud computing, big data analytics, and complex event processing, is now scaling in pre-funding stage. Some of the clients include Cisco Systems, Applied Mateirals, Huawei, Agilent, HP, Foxconn, Fletronics, and Sanmina that are using this software to transform their engineering and manufacturing operations. The company is expanding core engineering and product development team and looking for high caliber, senior software developers, with interest in working with cutting edge technologies in a high energy entrepreneurial environment.
Responsibilities include: Being involved in all stages of SDLC including analysis, design, implementation, testing, documentation, and release; Participate in multiple projects with changing requirements; and Maintain contact with clients/ partners to provide solution support and updates.
Requirements include: 4-6 years of software development experience; Software Development experience; ASP.NET with MVC, JQuery; Comfortable in data modeling, developing stored procedures, and triggers; and Readiness to learn new technologies quickly. Windows Workflow Communication Foundation 4.0; Biztalk RFID server skills; Windows Mobile Development experience; and Exposure to Windows Azure.
The position is located in the San Francisco Bay Area. Telecommute is okay but may need to attend client team meetings. Duration: 6-12 months to full-time. Terms: 1099, corp-to-corp, contract-to-hire, no visa sponsorships. Pay: rate negotiable. Open to considering excellent part-time candidates.
Program Manager – Santa Cruz, CA
A contract manufacturing company, near South San Jose, has an immediate opening for Program Manager.
Responsibilities: Managing the processes by which the company designs, develops, tests and releases for production the tooling, assemblies, equipment, and facilities required to meet customer needs; Act as primary focus for NPI for customer products, directing development and transfer to manufacturing; Supporting the Sales Department in the technical aspects of new business development and customer relations; Supporting the Manufacturing Department to resolve design issues impacting the manufacturing process; Supporting the Quality Department to diagnose and document the root cause of unacceptable product and process variation; Participating in the management of the company as a member of the Management Team.
Responsibilities also include: Take charge of projects assigned and charts status; Drive customer project requirements, reporting the customer needs to management; Lead cross-functional resources, organizing a productive, capable, and skillful project team with Manufacturing, Quality and Sales; Lead vendor qualification of machine parts with purchasing; Drive customer expectations.
JOB DESCRIPTION Program Manager; Develop trusting relationship with customer; Balance company goals with customer expectations, knowing when to push back; Support operational excellence (OE) and 5S programs; Recognize problems and eliminate them before they become crises; Track costs in labor, materials and resources with precision and accuracy; Preparing and submitting billing data to the Accounting Department; Report project problems to management; Collaborating with the Sales Department to develop new equipment and facilities that will meet customer objectives; Collaborating with the Quality Assurance Manager to develop process definition, measurement and improvement for newly developed tooling; Supporting the Manufacturing Manager in the selection of manufacturing materials, manufacturing equipment and control.
Requirements: Undergraduate degree in an engineering or technical discipline; Relevant experience may be substituted for the educational requirements; Five to ten years substantiated experience in the engineering function with companies that provide highly sophisticated manufactured products; Experience in the medical, bio-technology and other high technology industries strongly preferred; Experience in dealing with customers is strongly preferred; Must demonstrate expertise in a variety of concepts, practices and procedures common to the manufacturing industry; Project a neatly groomed, confident appearance and be effective with public speaking and direct client interface.
The environmental conditions in which the Program Manager will perform his/her duties are an open office. This position will require visits to client sites in all types of weather. The normal travel hazards will apply including driving and flying in a variety of traffic and weather conditions.
Other Requirements: The physical demands of the position are listed in accordance with the requirements of the American with Disabilities Act. They are outlined on the attached Checklist: Good reading, writing and verbal skills to communicate clearly and effectively in the English language to customers and company personnel; Intermediate capability in engineering and project management software; Computer literate in Word, Excel and Power Point with full competency in sourcing Internet material; Ability to maintain a flexible work schedule to meet the demands of the job. Some evening and weekend work may be required; High tolerance for stress and deadlines
Performance Criteria: The Program Manager’s performance is satisfactory when the following have occurred: New programs have been completed to the satisfaction of management and the customer; Responses to Requests for Quotes are submitted to the Sales Department when committed; The management team is always informed of the status of new programs; Billing information is submitted to the Accounting Department in time to support the billing process; Required reports are accurate and submitted on time.
Pharmacologist with Large Animal Survival Surgery Experience: San Jose, CA
A dynamic company, founded by a veteran leader, 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 candidate must have hands-on research experience including in vivo experience esp with large animal models during their doctoral and post-doctoral training period. The ideal candidate will have a Ph.D. in Physiology/Pharmacology or any other related Biology discipline or a DVM with research experience. The individual is expected to have a breadth of experience in both 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 individual 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 individual will set up and run a variety of routine in vitro research paradigms in house 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 individual will work with a multidisciplinary team of experts and provide biology support with minimal supervision on various ongoing projects.
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
- 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.