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Lead Quality Engineer Medical

Company: Gener8
Location: Sunnyvale
Posted on: May 13, 2022

Job Description:

Principals only need to apply - No Agencies Please Job Title: Medical Engineering Quality Lead We are seeking individuals who are enthusiastic about developing medical technologies which will better people---s lives. Be part of a small team that will assure good quality practices throughout the entire development process. This is a matrix organization, and your team will work on multiple products in parallel and at different stages of maturity. Be smart, be flexible, be part of a team, and help us mature our methods while having fun along the way. Responsibilities: -- In the early development phase, you will assess the customer requirements to assure that they are comprehensive and can be converted to quantitative specifications. -- Represent both customer requirements as well as regulatory requirements by defining, defending, and tracking those requirements through the process (trace matrices). Contribute technically to early design development while balancing those requirements. -- With the help of other team members and support software, produce and ECO all relevant development documents for an ISO13485 product. -- Frame and phrase engineering questions in the context of quality management. Become a knowledge center for medical device development processes, and ISO 13485 design control, within the medical device engineering group. -- Lead both formal and informal verification testing of both software and hardware development efforts. -- Do technical investigations and provide solution options when appropriate. -- Understand the product in its entirety to lead risk management, verification planning and execution, and validation planning including formal FMEAs. -- As the representative of the medical device engineering group, you will follow the product beyond the engineering phase. You will interact with every group involved in product development. This will build your knowledge of the entire process and will enable you to give valuable feedback into the designs for future products. Education & Experience Requirements: -- B.S. or above in an engineering or science field -- At least 5 years of industrial experience developing commercial instruments, devices, or assays -- Ability and willingness to learn the concepts and methods of new technologies or technical fields, founded on a multi-disciplinary background from education or experience -- At least 2 years of experience working on a medical device, under ISO 13485 design control -- The industrial experience must include engineering verification or design validation -- Knowledge and experience of product life cycles in regulated markets and their associated activities, risks, nuances, and strategies -- Understanding of formal test methodologies for both hardware and software in regard to ISO9001 or 13485.

Keywords: Gener8, Sunnyvale , Lead Quality Engineer Medical, Engineering , Sunnyvale, California

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