Senior Design Quality Engineer | Medtech

As a leader in the medical device field, our client designs and manufactures state-of-the art products for OEMs as well as for their own portfolio. The environment is fast-paced and offers exposure to a number of next-generation projects as well as new product development.


Responsibilities


Responsible for contributing to the design, development and management of projects for new and legacy products, with a focus on Design Assurance activities of medical device products.

·       Conduct product design control activities for new and sustaining product development efforts

·       Support risk analysis activities, including design and process FMEA

·       Support Process/Design Validation/Verification activities, including software validation and IQ/OQ/PQ activities

·       Support Design Engineering in the creation of Design History and Technical Files

·       Interact with third-party test houses that conduct compliance testing of products

·       Assist regulatory department with FDA, CE, and other regulatory submissions

 

Requirements

 

·       Bachelor’s Degree in electrical engineering or similar engineering field

·       5-10 years of experience with engineering and development of Class II or Class III electro-mechanical medical devices

·       Knowledge of Design Controls and Risk Management: ISO 13485, ISO 14971

·       Authoring and maintenance of technical design documentation, such as design specifications, verification/validation protocols, and DFMEA/PFMEA

·       Working knowledge of statistical methods such as Minitab

·       Self-starter, with demonstrated ability to follow-through and strong attention to detail

 

Preferred

 

·       Experience supporting disposable and/or sterilized devices preferred

·       Knowledge IEC 60601, 62304

·       Experience with lasers and optical technologies desired

·       Prior start-up experience is a plus

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