Posts Tagged Quality Engineer

Jobs – May, 2022


R&D Engineer w/ Analytical Instrumentation, Systems Integration Exp – Sunnyvale, CA

There are several exciting opportunities for product development research associate/ technician/ engineers in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as competitive benefits package. Company is found by a veteran leader and focuses on development and commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. This role requires working with a multidisciplinary team of engineers, scientists and manufacturing personnel. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.

Responsibilities

Testing, development and optimization of functional biochips, fluidic cartridges & analytical instruments; Support document prep; Use Good Documentation Practices (GDP) while authoring Experimental summaries, DOPs, SOPs, batch records (BRs) and forms (FRs) for various unit operations; Process development & optimization related to biomolecular sensing; Support all aspects of technology transfer to & from development partners; Develop, test & execute QC procedures; Process troubleshooting to determine root cause & find possible engineering solutions.

Requirements: MS in bio-, mechanical-, electrical- or chemical engineering, chem or biochem, or related; 5+ years hands-on R&D, engineering or product development and project/ people management experience. Experience in developing custom equipment by collaborating with external vendors or internal engineering resources; hands-on experience in mechanical design and in building & operating electronic systems; Proficiency in CAD design; Experience w/ statistical analysis software as well as with instrument-oriented programming language(s) (e.g. Python; LabView); Experience with standard biotech laboratory and/or manufacturing equipment & working with biological or biochemical systems (e.g. proteins, nucleic-acids, cells and/or bio-organic molecules); Experienced using diverse analytical instruments e.g. oscilloscopes, DAQ interfaces; Experienced in cGMPs & in authoring DOPs, BRs, FRs; Experience in V&V of instruments and processes; and Knowledge of data analysis methods.

Optics & Photonics Research Scientist/ Engineer w/ microfluidics/ lab-on-a-chip Exp – Sunnyvale CA

This is an exciting opening for interdisciplinary research scientist/ engineer with experience in photonics, material science and/or biological applications product development to work in multi-disciplinary team, in developing, testing, optimizing and troubleshooting aspects related to novel diagnostics technology platform & to work with novel detection systems, complex fluidic systems and assay optimization on prototypes and automated systems. The compensation will be competitive and includes stock with a huge potential as well as a competitive benefits package. Company is founded by a veteran leader & focuses on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. Part of the activities might be conducted in a BSL2 laboratory area and could involve the handling of human patient fluid samples. Other activities might be conducted in a CER (controlled environment) setting.

Responsibilities: Support optofluidic platform technology development, & development of single-molecule detection technology with novel reagents & fluidic cartridges, as well as instrumentation for detection, sample preparation & corresponding software; Support diverse aspects related to mid-stage development of a bio-chip based, optofluidic diagnostics platform; Apply diverse knowledge of design principles, practices & implementation in complex systems & assignments; Design, optimize, test, & support validation of optofluidic chips, optical/fluidic interfaces, sample processing technology & instruments, in collaboration with other groups & external suppliers; Develop, evolve & maintain custom optoelectronic systems used for testing and characterizing optofluidic systems; Analyze & present data including images, time traces, assay flows, optical spectrums; Conduct statistical analysis & build/implement/test models for stochastic, high-volume data; Support all aspects of technology transfer to and from internal and external partners; Interface with internal resources and external vendors to design, test & validate equipment.

Requirements: BS/ MS in bio-, mechanical-, electrical- or chemical engineering, chemistry, physics, biochemistry, or related plus 1-5 years hands-on R&D or engineering experience; Extensive theoretical and hands-on experience in optics/photonics; Experience bridging the fields of photonics/optical engineering, microfluidics/lab-on-a-chip & statistics; Exp in design of optical systems (free space & chip based) & in using simulation software eg. ray tracing software for system design & FEM/FDM/BPM etc for chip design: Proficiency in statistical analysis (e.g. Python, JMP, Matlab, etc.) as well as instrument-oriented programming language(s) (e.g. Python; LabView); Experience in using diverse, analytical instruments such as oscilloscopes, DAQ interfaces, UV-VIS spectrometers, scanning electron microscopes (SEMs), fluorescence microscopes, etc. Expertise in optofluidics, Hands on ability to work-with/manipulate/couple optical fiber and respective components, Proficiency with digital/analogue signals & systems; Experience simulating in Multiphysics environments (e.g. Comsol, Lumerical) and Circuit design and simulation experience are all HUGE PLUSES.

Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!

Software Engineer  w/ experience building products in multi-disciplinary envt – Santa Clara, CA

This is an exciting opening software engineer with experience software & hardware development to design, develop & implement a growing suite of bioanalytical solutions comprised of integrated biochips, proprietary reagents & custom instrumentation. The company is founded by a veteran leader and is developing single molecule detection technology, and is focusing on development & commercialization of biochip-based detection platforms for ultra-high sensitivity diagnostics & bioanalytical applications. 

Responsibilities: Lead / Support Software, Firmware & UI development aspects related to the development of novel, diagnostic instrument platforms; Develop control/analysis software for RUO (Research Use Only) & FDA regulated instrumentation; Develop / Contribute to a custom user interface for scientific & medical diagnostic systems; Support all aspects of technology transfer to & from internal & external partners; and work with a multidisciplinary team of experts.

Requirements: B.S. with 3+ years of relevant experience (Level I), B.S./M.S. with 7+ years of relevant experience. (Level III). Requirements also include, Significant experience with instrument-related software engineering using C#; Experience with Python programming; Exp w/ industry coding best practices (Git management, unit testing, documentation, etc; Experience developing, implementing, consuming & supporting contracted APIs. Also preferred: Experience with interface standards (e.g. GraphQL, OpenAPI, etc.); Experience with firmware level interaction (e.g. C). Experience with delivering quality conformant software (e.g. SaMD); Experience with complex data analysis challenges; Ability to develop custom equipment with external vendors and/or internal engineering resources.

Finally, ONLY CANDIDATES PROVIDING A POSITION SPECIFIC COVER LETTER WILL BE CONSIDERED!

Senior Manufacturing Engineer – S. San Jose, CA

Bay Area start-up focusing on improving healthcare delivery through state-of-the-art catheter development has an immediate opening for senior manufacturing enginee, to support the development and production of innovative catheters ensuring high reliability, regulatory adherence, and cost-effective manufacturability.

Requirements: Minimum 10 years history of experience in medical device manufacturing environment; Proficiency in Solidworks; Experience writing protocols & test reports; Experience using inspection and test equipment (vision systems, tensile testing) are required.

Responsibilities: Support manufacturing activities; Spend time on the manufacturing line with the assemblers to improve processes & increase quality; Develop assembly & test fixturing; Create, validate & document new manufacturing processes; Write protocols & test reports; Prepare manufacturing lines for significant scale up; Conduct process verification & validation activities; Initiate failure analysis in manufacturing; Design, write & perform equipment qualifications & process validations; Facilitate transitioning development products to full scale production line; Collaborate with existing suppliers & bring up new ones with an eye towards partnership & efficiency. 

Associate Director/Director Validation – SJ  /QUALITY – QA TEAM

There is an immediate opportunity for Director of Validation in San Jose, CA in a pharmaceutical company with novel drug delivery technology. The company recently had an IPO event and the stock has held very well and the technology holds promise to be a game changing improvement in the quality of care for many patients. The company has a world class team in place. Director of Validation is a hands-on role responsible for the execution of validation activities: To develop & implement harmonized validation processes & practices; Develop a qualified team; Manage validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment. 

Skills & Experiences: 

Responsibilities: Ensure development & implementation of validation strategies & internal SOPs; Write & review qualification & validation documents; Lead & support qualification & validation of cGMP equipment, facilities, utility systems, cleaning & manufacturing processes; Develop & maintain risk based, quality driven procedures & practices; Lead risk assessment activities; Identify, hire & develop, manage & support company’s validation expertise; Support change control program with respect to facility, utilities, equipment, cleaning & computerized systems validation changes; Evaluate validation impact of manufacturing process changes & equipment upgrades; Complete activities related to regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.; Ensure Quality meets or improves on budget, cost & efficiency targets (KPI’s) in line with business objectives; Support QA activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs; Other duties/activities may be necessary to support departmental or company goals. 

Skills & Experience: BS in life science or engineering; 10+ validation exp in bio/pharma industry; 5+ years of supervisory/managerial experience; Knowledge Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) & validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500; Knowledge of international & domestic cGMP regulations for pharmaceutical manufacturing; Technical writing, problem solving & analytical skills; Ability to review, analyze, summarize & interpret data, draw conclusions & make decisions/ recommendations; and Experience in project management. 

Quality Assurance – S. SJ

There is an immediate QA position available for support & performance of QA/QS functions/activities and adherence to applicable regulatory standards for medical devices. This is a vascular company founded by a seasoned entrepreneur whose previous company had $1B+ exit. This opportunity will offer competitive salary plus stock with huge potential.

Skills & Experience Required: BS in Science related area; 10+ yrs experience in FDA regulated industry; Exp with Quality Assurance practices & systems; Knowledge of ISO 13485 and FDA 21 CFR 820; MasterControl administration/process ownership; Maintain compliance of a certified QMS related to configuration control, document control, and change control. ASQ Certifications are a plus.

Responsibilities: Support devet & maintenance of QMS, ensuring alignment of corporate operations applicable regulations; Serve as system administrator for MasterControl Electronic Document Management and Training System (EDMS), including responsibility for configuration, user training, account management, training course creation and assignment & assessment of upgrades & patches. Maintain validated state of system throughout system lifecycle. Manage, process & track controlled documents from the Document Change Order (DCO) process until document approval or retirement, including updating related controlled documents; Revise controlled documents as appropriate & ensure timely reviews. Manage electronic approval of records/documents via DocuSign; Monitor & track completion of quality system records including CAPA, Deviation, and NCMR; Monitor training compliance & report any issues to management; Maintain Approved Supplier List (ASL) and ensure supplier files are current; Perform raw data review in support of technical reports and regulatory filings & Issue, track, and perform quarterly audits of laboratory notebooks. Assess corporate operations against quality system regulations, issue identification/ resolution including proper and timely documentation; Prepare quality metrics & reports; Facilitate & conduct internal & external audits; Perform history record review & disposition of device batches. Review/approve facility records as needed (pest control reports, cleaning logs, and environmental monitoring reports & Manage archival of hard-copy records.

Senior Manager CMC, Analytical Development – North San Jose, CA

There is an exciting job opportunity in San Jose, CA, to work on novel projects involving drug-device combinations for treating chronic diseases & participate in method and tech transfer from R&D to Manufacturing as appropriate. This is an exciting opportunity in a rapidly growing company to work with a world class team, on game changing technology with HUGE potential.

Requirements include: BS/MS in sciences PLUS 5+ years relevant bio/pharma experience; biologics analytical development exp in biophysical techniques & analytical characterization of peptides & proteins; solid oral dosage and/or parenteral sustained release formulation exp, exp in process development from early to late phase development; experience of working in GLP/GMP regulated environment, drug-device combination exp; knowledge analytical techniques such as various HPLC modes & detections, LC-MS, CE-SDS, peptide mapping, ELISA, cell-based assays, etc, for product characterization, comparability testing and PK/PD analyses; Exp in method validation and specification setting; Assessing chemical & physical stability of formulations, identifying stability, manufacturability, & performance critical quality attributes. Experience in protein purification & biologic formulation is a plus.

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JOBS – February, 2015


Please see below opportunities and send resume as an attachment to wd_darshana at hotmail dot.  My imminent openings are for Quality Engineering and for Software Engineering (both for medical devices).  Please also notice contract opportunities at the end.  All US opportunities are for US based and local candidates.  Opportunities exist in China that are open to all and you can see description in my previous blog athttp://bit.ly/15STeDw specific one is for Director of Analytical R&D in Suzhou. When sending a resume, please mention job you are interested in, in the subject line and in the email include a brief summary of how best the job description matches your background and where the gaps are.

Senior Electrical Engineer – Austin/ San Antonio – TX

A company working on innovative range of products, has an immediate opening for senior electrical engineer with class III device experience.  Experience with closed loop, analog design hardware, microcontrollers, actuators  and ultra low power consumption circuit design highly desired.  More details will follow soon but if interested, please send resume as an attachment (with some details in email) at wd_darshana at hotmail dot com.

Senior Software/ Algorithm Engineer – Fremont, CA

A company providing innovative diagnostic & therapeutic products &  services to enable interventionalists in providing superior patient care, has an immediate opening for Senior Software Engineer, in Fremont, CA.  Position Summary: This position will be responsible for developing the next generation of image processing algorithms for company’s revolutionary medical devices for cardiovascular business. Individual will participate in object-oriented software development projects using C++ and Qt for a Linux environment. Communicate effectively, as well as to present information to a group in a professional manner. Work cooperatively as part of a team with people from various facilities and technical backgrounds.

Primary Duties and Responsibilities:
Design, develop, and optimize next generation image processing algorithms
Perform lab research and algorithm testing
Develop multi-threaded software for desktop applications
Design code for maintainability and unit tests
Identify, evaluate and mitigate technical project risks
Support formal verification and validation process and participates in transfer of products from R&D to manufacturing
Team player working in a geographically distributed team
Accurately estimate time and resources for completion of specific features/project
Assist in maintaining ISO certification and 510(k) submission requirements

Qualifications & Required Skills:
Minimum BS degree in Computer Science, Computer Engineering, Electrical Engineering, Applied Math, Biomedical Engineering, or related field; Strong background in image processing; 5+ years of software development experience; Excellent coding skills in C/C++; Proficiency in MATLAB; Experience designing object-oriented and distributed software; System level architecture design experienc; Experience with source code management systems like GIT, SVN, Clear Case

Preferred
Experience developing software for medical device applications for user interaction and control
Experience with medical imaging algorithms like segmentation, co-registration, 3d reconstruction
Experience with python, DICOM, OpenGL graphics
Other: * Travel requirements are moderate. Travel to facilities would be about 2 – 3 days duration each trip with total travel expected to be less than 20%.

Please submit resume at wd_darshana at hotmail dot com, with answers to following questions in the email.  This is client HR’s requirement. 
Please provide information on your formal education:
Please describe your software engineering experience as it relates to design, proof-of concept, detailed design, code, unit and integration testing:
Please describe your experience utilizing UML modeling language, DiCom, MFC, BOOST, STL and C++ :
Do you have experience working Linux OS environment? If yes, provide more detailed information:

Senior Design Engineer with Embedded Hardware & Firmware Skills – Santa Clara, CA

A reputed contract engineering company has an immediate full time opportunity for  a Senior Design Engineer with Embedded Hardware & Firmware Skills.  A rounded individual is desired who has an interest and ability in a wide range of technologies.  The successful candidate will lead a group of engineers from time-to-time and may be required to act as the primary interface to the customers at times.  The company designs devices, firmware, and software for other companies and has a reputation for quick response with high quality work.  The person must enjoy working with customers and have good communication skills.  The person must work well on a team of high performing engineers.  The person needs to be organized.  The person must work well with others and be flexible as schedules and priorities change.

Technical requirements: Ten years of experience in embedded system design engineering is required.  Ability to supervise others is highly desired.  The person should have experience designing circuits with microprocessors from PIC to ARM, FPGAs, Bluetooth, and WiFi as well as experience with programming in C or C++ on these devices.  The person must enjoy learning and be able to learn quickly.  The ability to design and program FPGAs is desired.
This could be a work-at-home job, or work at the company site, in Santa Clara, CA.

QUALITY ENGINEER – Santa Cruz, CA

Summary:  Medical device design and manufacturing company, located near Santa Cruz, CA, focusing on custom injection molded plastic parts, has an immediate opening for Quality Engineer.  Position focus is on providing support in the development and maintenance of company’s quality systems, support activities related to the development and qualification of new product development for medical device components and assemblies as well as supporting existing products.
Responsibilities
* Write FMEAs, review and write protocols and reports for new products
* Ability to multitask on a variety of Quality System compliance and improvement initiatives in a hands-on dynamic environment and be involved with the design, procurement, validation and qualification activities including test, inspection and medical device contract manufacturing service processes.
* Responsible for the facility measurement equipment calibration and maintenance program.
* Collects, collates and analyzes manufacturing data for warranty and nonconformance to determine and report product quality trends.
* Conducts analysis of inspection and tests of a routine degree of complexity and provides recommendations accordingly. Develops quality control inspection requirements and techniques to achieve measured improvement. * Implements 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 and subassemblies for medical device products to support quality compliance and shipment goals as workload requires.
* Assist in the development and implementation of Quality System processes.
* Attend various product meetings with Engineering, Sales, Support, Marketing, and customers to address product requirements, customer concerns and training issues. Work toward and support Company/Department/Team 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 the reporting, analysis, and 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 lor corrective preventative 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: 5 – 7 years’ experience in Quality, medical device, regulatory, and or a medical device manufacturing environment; BS in Bachelor of Science in Quality, Business, Mechanical Engineering, Engineering or related field; Certification, CQE, CQA a plus; Experience as an ISO Lead Auditor desirable; Must be able to communicate effectively at varying technical levels with a customer audience; Hands-on manufacturing experience in mechanical or medical device assemblies. CMM, MicroVu, Vision Systems Programming experience; Working knowledge of U.S. and international medical device regulations is desirable Working knowledge of desktop computer office software, Visio Tools, CAD software and e-mail is required; Excellent verbal and written communication skills; Flexibility to handle multiple tasks and meet timelines; Excellent analytical and problem-solving skills combined with a strong technical presence.

Senior Quality Engineer – Austin/ San Antonio – TX

A company working on innovative drug delivery technology has an immediate opening for senior quality engineer. Great opportunity to work at grounds level and grow into leadership role, in addition to the upside of stocks.

Key Responsibilities:
* Lead QA for: R&D- design, development, V&V phases including hazard/risk analysis and mitigation, DOE and related statistical design and analyses, GDT, design reviews, audits/compliance; Manufacturing including process development, qualification and validation, IQ, OQ, PQ, part/component selection, sterilization and packaging development and validation
* Develop and implement QA systems to be compliant with applicable international and national standards such as ISO 13485 and regulatory requirements of FDA CFR 820 and other bodies for Class III implantables
* Implement productive relationships with R&D and manufacturing suppliers and partners
* Work in a matrixed organizational structure to support company’s facilities, including the respective incubated companies, projects and technologies with an appropriate QA system for each segment
* Educate colleagues and support in-house uptake & implementation of these systems organization-wide* Support the following functions: Regulatory Affairs: provide appropriate documentation and materials to support filings for US and international trials and approvals; Intellectual Property: supporting documentation; Business and Commercialization, including due diligence documentation
* Develop & implement documentation systems for these business functions, including electronic systems, with help of to –be-hired Documentation Specialist

Key Qualifications
* Designed and implemented QA systems for implantable medical devices and drugs. Combinatorial device and Class III experience desirable. At least 10 years experience, >15 years desirable*
* Bachelor’s degree in Engineering or in an equivalent field required, with ASQ certification (CQE, CRE, CQM, CSSBB) desirable
* Led and grown QA organizations with a hands-on, leadership- by-example approach
* Demonstrated working experience with electronics hardware and software, biomaterials, drugs, drug delivery, and mechanical technologies while supporting multidisciplinary teams: engineering, biological, manufacturing, regulatory, intellectual property, clinical and business.
* Excellent and demonstrated grasp and use of statistics in R&D and manufacturing including DOE
* Supported multiple complex projects and start-ups: able to prioritize.
* Developed and implemented design controls, documentation, and design procedures, protocols
* Developed and implemented manufacturability, and related process flows and controls, and selected qualified vendors to manufacture Class III implantable devices
* Strong technical skills with demonstrated ability to provide solutions to a variety of technical problems of varying scope and complexity
* Analytical data-driven problem solver and team player, organized and an excellent communicator

Key Job Parameters
* Full-time position located in Austin/ San Antonio, Texas
* Some travel (~10%) may be necessary to meet job responsibilities
* Report to VP, Product Development


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Jobs – April, 2014


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 require several years of industry experience and are only for local candidates, with valid US work visa (when need arises for applicants with other types of visas, I will mention that under that specific opportunity).  Also note, opportunities at the top are hot and the ones lower down may be at various stages of being filled or not burning needs.

Quality Engineering opportunities- Middleton, MA

A company located near Middleton, MA, and recognized as a pioneer & global leader in healthcare technology & innovation for assisting or replacing the life-sustaining pumping function of the failing heart, has following immediate Quality Engineering opportunities.

Quality Engineer – Console Program Support

Requirements:  Bachelors in EE & 5+ years implantable medical device experience and Design Control & risk management experience required.  CQE or CRE certifications are preferred.  Comp: $80-95K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; Program support for console includes review of design/software verification & validation protocols & reports; conduct design control compliance reviews, performs risk analysis, and FMEAs; Instill reliability mindset within team & provide guidance on reliability methods to team.

Quality Engineer – Disposables Program Support

Requirements:  Bachelors in EE highly desirable.  1 year medical device experience & CQE or CRE certifications are highly preferred. Comp: $60-85K
Functions: Understand customer complaint trends & patterns for root cause understanding & corrective actions; program support on heart pump disposables including review of design & process verification and validation protocols & reports; conducts design control compliance reviews, performs risk analysis, and FMEAs.

Senior Embedded Development Programmer – Mountain View, CA — Hot

A top notch product development company with a reputation for completing difficult projects on time and on budget, has an immediate opening for a programmer. The company consults for companies making wearable devices, home health, products for the aging, medical devices etc & is known for work with sensors, wireless, and motion control.

Requirements:  10+ years experience in engineering design; Embedded programming skills on Windows and/or Linux; Experience with wide range of processors; Familiarity with digital circuits; Ability to design digital circuits. Ability to design analog circuits & supervisory experience would be a plus. The person needs to enjoy working with customers and have good communication skills.  The person needs to work well on a team of high performing engineers.  The person needs to be organized.  The person needs to work well with others and be flexible as schedules and priorities change.

Director Quality Engineering – San Jose, CA

There is an exciting opportunity for Director Quality Engineering with strong capability and experience developing quality innovative medical devices.  This position is responsible for effectively leading multi-project quality engineering efforts of the organization through technical expertise, interpersonal skills and a clear vision for execution.

Responsibilities: Manage resources to accomplish multi-project product research, development and manufacturing; Contribute to strategy and management of GMP/GLP operation; Provide Quality Engineering support as necessary to meet organizational objectives; Maintain quality management systems necessary for development, including clinical evaluation; Develop quality plans and data analyses for execution and review with leadership team; Develop test strategies DOEs and test protocols to test developmental medical devices and manufacturing processes; Work with R & D and Operations to establish quality requirements at all phases of product/process development and manufacturing; Design, schedule, and if necessary, performs specific testing for existing and new products including supporting design and process validations, qualifications and first article inspections; Conducts supplier evaluations including supplier audits; Ensure that appropriate level of quality/reliability in purchased components is specified; Identify product/process problems and ensure appropriate corrective actions are taken and verified to be effective in eliminating problem; Remain current on developments in field(s) of expertise and industry trends; Mentor junior staff members

Skills Required: Demonstrated leadership of technical teams in medical device field; Demonstrated aptitude for and mastery of Quality Engineering principles; Demonstrated problem solving skills in a multidisciplinary environment; Exemplary analytical, organizational, written and oral communication skills; Proficient with statistical analysis for engineering and manufacturing; Strong ability to operate independently and as a team member; Teamwork: ability to work closely and effectively with team members and colleagues across engineering as well as non-engineering disciplines such as biochemistry, physiology, pharmacology and chemistry; Knowledge of implantable medical device design control and manufacturing processes ; Deep experience in safety standards for a variety of medical device types; Knowledge of biocompatibility, packaging and sterilization quality assurance; Demonstrated ability to interface effectively with professionals in the medical and biological sciences; Demonstrated knowledge of sound design principles, regulatory requirements, and product and process validation procedures; Demonstrated proficiency with computer aided design software and hardware familiarity. Formal training on systems and software is desired.

Also required: Bachelor’s degree or higher in Engineering; Ten years minimum experience in medical device engineering (Quality, R&D and Manufacturing) with demonstrated capability and thorough understanding of quality management; Three years minimum direct personnel management and related leadership experience; ASQ Certified Quality Engineer certification preferred; Must have experience in GMP electro-mechanical product design and manufacturing; Requires highly developed leadership skills and experience, including the ability to map task interdependencies, multi-task, prioritize such tasks, meet deadlines, and develop, monitor and live within budgets as well as the demonstrated ability to forecast major milestones.  Must be skilled at delegation, follow-up, and team building.

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QA Manager – Mount Laurel, NJ

An innovative medical device company working on treatment of chronic heart failure (“CHF”), has an immediate opening for a QA Manager.  Salary commensurate with experience and will be in the range of $125-145K.

Responsibilities: Management of Quality Systems department; Direct supervision of Shipping Coordinator and Documents control; Day to day operation of all quality functions; Assure compliance with domestic and international quality requirements; Ensure comprehensive Quality Systems programs to support multiple product manufacture; Prepare and execute all external & internal audits; Work with contract manufacturer to ensure that devices are manufactured in compliance with US and international quality system requirements; Review all product complaints & ensure timely reporting of those events to domestic and international regulatory agencies as necessary; Participate in product development teams on behalf of Quality Systems. Identify and resolve quality issues throughout product development process to assure successful audits and regulatory filings; Manage, supervise and train staff, oversee projects ongoing within departments, carry out departmental administrative duties; Review and revise quality system documentation to ensure compliance with domestic and international quality and regulatory requirements; Schedule and complete timely management review presentations; Manage the document services function to ensure that quality systems documents, records and regulatory submissions are controlled; Schedule, conduct and assist in responding to internal audits; Schedule and conduct supplier audits; Maintain program to ensure adequate training of personnel on quality system documentation; Ensure that company employees are trained on the Quality Systems Regulation and key international regulations and standards; Manage the program for handling product returns, returned product evaluations (and repair/rework, where applicable), complaints and customer feedback in accordance with internal policies and procedures; Maintain a functional CAPA system in compliance with applicable regulations; Maintain ISO 13485:2003 facility registration in accordance with applicable standards; Provide guidance and supervision for Shipping/Receiving Clerk as it relates to completion of receiving inspections and other quality related functions; Ensure that the Quality Systems function is carried out in accordance with GMP and ISO directives.

Requirements: Minimum Bachelors level degree with 8-10 years’ experience in Quality area or related experience in medical device arena; Good working knowledge of domestic and international requirement and regulations; Excellent organizational skills and analytical and problem solving abilities; Strong verbal and writing skills and good interpersonal and leadership skills; Strong PC skills include Windows environment, Excel and internet.  Spanish language skills desirable.

Post Doc Opportunity – TX & CA 

There are immediate exciting opportunities that can lead you a fantastic career path in medical device engineering.  A medical device company, found by a veteran leader of several successful companies, has several post-doc openings in Biomedical with Electronics/ Electrical Engineering – with experience in heart/ brain related implantable devices in Texas and couple of opportunities with broad Biomedical/ Mechanical and/or Chemical Engineering background.  Hands-on experience is essential.  For Electronics Engineering, experience with hands-on circuit design, embedded systems design, prototype building or experience with battery-powered, low powered systems, etc. may be desirable.  The company is working on exciting cutting edge technology to deliver large drug molecules orally.  That and other research products pertain to solutions that are a unique blend of traditional device technologies such as electronics, software, mechanical engineering, and material science, as well as pharmaceuticals, protein chemistry and cell biology.  Focusing on a broad range of technology and scientific disciplines, the company is seeking to address most complex unsolved or poorly treated clinical needs with highly innovative novel solutions.

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JOBS – March, 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.

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