Senior Design Quality Engineer (Medical Device) job in San Francisco, USA

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Last Name*

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First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

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Are you an employer or a jobseeker?*

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Job type: Permanent

Discipline: Good Manufacturing Practice (GMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP)

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is looking to hire a Senior Design Quality Engineer of Medical Device for a leading biotechnology company located in San Francisco, CA.

Job Responsibilities:

Support new product development and design changes to existing products in ensuring compliance with company's Quality System
Serve as a technical resource for requirements, risk, verification and validation, process validation, usability, statistical analysis, Design Transfer, etc.
Support company Capital Equipment design development activities primarily focusing on electrical design and assess the reliability of new designs.
Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files
Develop and implement product quality plans, risk management plans to ensure high degree of assurance that specific design and processes will consistently and continually produce a product that meets specifications and critical to quality attributes. Lead design related Risk Management activities including improving the risk management process

Skills and Requirements:

Bachelor's degree or Master's degree in, Electrical Engineering
Minimum of 5 years of experience working in medical device industry
Background in electromechanical and software devices
Must have working knowledge of CFR 820, ISO 13485, ISO 14971, IEC 62304, IEC 62366
Experience with medical device HW testing (IEC 60601, IEC 60529)
ASQ CQE, CRE, CSQE, or CQA certification preferred
Must have a solid understanding of statistical processes and techniques
Understanding of SW Development Lifecycle, SW Architecture, and Configuration Management
Proficient with software and electrical development and collaboration tools (e.g., Jira, JAMA, GitHub)
Must be detail orientated, well organized and have excellent communication skills. Must work well with team
Must be able to accomplish objectives with minimal supervision
Experience in conducting product Investigations
Must be detail-oriented with strong written and oral communication skills
Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations
Ability to write reports, customer facing correspondence, and procedure manuals
Ability to effectively present information and respond to questions from other internal groups, clients, customers, and the general public
Ability to work with mathematical concepts such as probability and statistical inference
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists
Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

If you are having difficulty in applying or if you have any questions, please contact Jacqueline Zafrani at (+1) 213-893-4997 or j.zafrani@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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