Senior Design Quality Engineer (Medical Device)

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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