Posts Tagged Verification and validation
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. This quarter seems to be all about Engineering Jobs (more specifically in Software), but Quality Engineering and CRA opportunities in New York, New Jersey and San Jose, CA are also very hot. – see below.
Software Developer – Mountain View, CA
Right now we are witnessing the onset of industrial internet paradigm where integration of big data with big machines is fundamentally changing everything. This company provides innovative, modular, scalable and world class software solutions in this industrial-internet paradigm by leveraging sensor technologies, cloud computing, big data analytics and complex event processing. There is an immediate opening for software developers with Windows skills.
Responsibilities: Be involved in all stages of SDLC, including analysis, design, implementation, testing, documentation & release; Participate in multiple projects with changing requirements; Maintain contact with clients/partners to provide solution support& updates; Be ready to learn new technologies quickly.
Requirements: 4+ years of software development experience in ASP.NET with MVC, JQuery; Be comfortable in data modeling, developing stored procedures & triggers; Windows Communication. Also preferred: Windows workflow foundation 4.0; Biztalk RFID server; Windows Mobile development; Exposure to Windows Azure
Location: SF Bay Area. Telecommute okay, but may need to attend client meetings: 6-12 months to full time. Pay rate: $65 an hour but negotiable based on experience.
Test Engineer – SF Bay Area
Right now we are witnessing the onset of industrial internet paradigm where integration of big data with big machines is fundamentally changing everything. This company provides innovative, modular, scalable and world class software solutions in this industrial-internet paradigm by leveraging sensor technologies, cloud computing, big data analytics and complex event processing. Below is description for Test Engineer with the company.
Responsibilities: Be involved in all stages of SDLC: including analysis, design, implementation, testing, documentation & release; Participate in multiple projects with changing requirements: Maintain contact with clients/ partners to provide solution support & updates; Be ready to learn new technologies quickly.
Requirements: 4-6 years of software development experience in ASP.NET with MVC, JQuery; Be comfortable in data modeling, developing stored procedures & triggers, Windows Communication. Also preferred: Windows workflow foundation 4.0; Biztalk RFID server; Windows Mobile development; Exposure to Windows Azure.
Location: SF Bay Area or Austin, TX. Telecommute possible, 6-12 months to full time. Pay rate: $35 per hour but negotiable based on experience.
Junior & Senior CRA – Orangeburg, NY
Medical device company with innovative treatment for chronic heart failure, located in Orangeburg, NY, has openings for Jr & Sr. CRA. (Awaiting JD for Senior CRA but feel free to send resumes).
Functions: Manage & organize administrative aspects in clinical department, create & maintain site personnel contact information, mass mailings, study binder preparation & distribution; Collect regulatory documents, ensure accurary, record reciept of key documents & contact site regarding missing records; Collect & Review study-related tracking systems to determine & report status of clinical trial documents. Send notifications to the clinical trial sites regarding their IRB renewal dates IRB; Maintain & audit study related files in compliance with department standard operating procedures; Review monitoring reports & assist with the follow-up & resolution of noted observations; Work with clinical trial sites to ensure all required testing is forwarded to & received by the Core Laboratories; Consistently use study tools & training materials & comply with standard operating procedures and policies; Perform data entry; Arrange periodic meetings for the Physician Adjudication Committee & assist the Clinical Director with the preparation & conduct of the meetings.
Requirements: Bachelor’s degree in life sciences or related, with 1-2 years medical device clinical research experience; Experience in communicating with hospital administrators and clinical research nurses; Working knowledge of FDA regulations and Good Clinical Practices; Excellent organizational skills; Good problem solving skills; EDC experience a plus; Conscientious person with an outstanding work ethic & strong personal discipline.
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.
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.
Senior Manager Quality Engineering – San Jose, CA
There is an exciting opportunity for Senior Manager, 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.
Machine Learning/ Computer Vision Software Engineer – Mountain View, CA
There is an immediate opening with a company working to quickly get life saving technology to market. Company offers an excellent benefits plan, and grants stock options to all employees.
Responsibilities: Work on challenging problems in computer vision and machine learning that will have a direct impact globally on the healthcare and safety of patients; Research, prototype & develop novel computer vision and machine learning algorithms; Work within a cross-functional team of computer vision, software, hardware and mechanical engineers in a medical device environment
Requirements: Expertise in machine learning algorithms (classification and clustering) for pattern recognition: Decision trees, Support vector machines, Neural networks Expertise in Computer / Machine Vision, Feature extraction, Segmentation, Color and shape analysis, Object and character recognition Hands-On Expertise in Open CV, MATLAB, C++ or C#. Also required, M.S. or Ph. D in Computer Science with a focus on computer vision and/or machine learning; Strong skills in machine learning & computer vision, with a deep understanding of the methods & algorithms used in this domain; Strong analytical & problem solving skills; Track record of hypothesis driven experimentation & problem solving; Up to date with the latest publications in the machine learning and computer vision community; Excellent written and verbal communications and the ability to work hands-on in cross functional teams; Highly motivated and excited to work in a fast-paced environment.
Senior Firmware Engineer (Mountain View, CA)
There is an immediate opening with a company working to quickly get life saving technology to market. This industry-leading technology platform (image processing, computer vision, pattern recognition, embedded software, hardware, and firmware) was built internally. This is a challenging environment with simultaneous multiple projects, aggressive deadlines and A+ team. Company provides excellent benefits plan, and grants stock options to all employees.
Responsibilities: Programming for embedded systems that utilize wireless communication channels, including Bluetooth, 802.15.4 radios, RFID and WiFi, Validate design concepts by designing, fabricating & debugging prototypes, Conduct & coordinate firmware testing activities, including unit testing, functional testing & regression testing, Support manufacturing by developing manufacturing test procedures, Collaborate on firmware architecture design strategies & requirements, Support product by creating & by composing functional & design documentation
Requirements: Proficient in high-level structured programming languages (e.g. C, C++); Proficient in Ultra-low Power Design techniques, Proficient in Wireless Communication techniques, Proficient is Motor Control Systems and State Machines, Skills for both implementing new firmware systems as well as analyzing and modifying firmware systems originally written by others, Proficient in developing code with resource-limited runtime environments, for embedded products, Proficient in low-level languages (e.g. Assembler, ladder) is a plus; Bachelors or Masters in Electrical Engineering and 5+ years of relevant experience.
Senior Java Software Engineer (Mountain View, CA)
This is an immediate opening with a company working to quickly get life saving technology to market. This industry-leading technology platform (image processing, computer vision, pattern recognition, embedded software, hardware, and firmware) was built internally. This is a challenging environment with simultaneous multiple projects, aggressive deadlines and A+ team. Company provides excellent benefits plan, and grants stock options to all employees.
Responsibilities: Design & implement company’s suite of products & distributed web applications using J2EE, Spring Framework, XML, Web Services, JMS, Servlets, JSP/JSF, and Hibernate; Design & implement easy-to-use, high-performance, high-quality, embedded, hosted & enterprise web-applications; Design & implement development platform & complex applications with limited or no direct supervision; Flexible & works well as part of a fast-paced interdisciplinary product development team
Senior Embedded Development Programmer – Mountain View, CA
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.
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.
If you are a professional in #healthIT, #digital health, #internetofthings, #cloud, #bigdata or related, I would say this is the conference, you don’t want to miss – It gives fabulous opportunity to network with 4000+ professionals. Check out great agenda, top notch speakers & panelists at www.tiecon.org. Register for #TiEcon (May 16 & 17 at Santa Clara Convention Center) at link http://tinyurl.com/kr2hkcw as my guest & enter promo code tievalue to get $100 discount (valid till midnight, May 1).
Healthtechnology conference http://www.healthtechnologyforum.com, focused on exploring pathways to sustainable health, is on May 20 in SF. Please register for the conference as my friend, with the discount code “HTF14-FriendOfOrganizer” and send me your first & last name at wd_darshana at hotmail dot com, to get $150 off the price of the ticket.
http://www.bio2devicegroup.org meets every Tuesday in Sunnyvale, CA. Morning meetings are free, wealk-ins welcome. If you would like to speak at one of our events, or for more information on any of our events, feel free to send me an email at wd_darshana at hotmail dot com and you can follow my updates on Twitter @DarshanaN.
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