Senior Design Assurance Engineer
Apple Inc
Santa Clara Valley (Cupertino), CA
Job posting number: #7150457 (Ref:apl-200478027)
Posted: May 19, 2023
Application Deadline: Open Until Filled
Job Description
Summary
The Health group is looking for a Senior Design Assurance Engineer to navigate, establish and implement quality processes in support of product development for novel Medical Device products. In this role, you will work with a multi-functional team and be the champion of Design Assurance and Quality Management Activities throughout the product lifecycle.
If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team and work closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into the hands of our customers.
Come join our team!
If you are passionate about the health space and want to have an incredible impact here at Apple, this could be the role for you. We are an efficient team and work closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into the hands of our customers.
Come join our team!
Key Qualifications
- 10+ years of experience in the medical device industry as a Design Assurance/Quality Engineer.
- Validated proficiency in U.S. FDA medical device regulations (21 CFR 820) and international standards (ISO 13485, ISO 14971, IEC 62304, 62366 and EU MDR).
- Hands on experience with medical device testing and certifications such as IEC 60601.
- Experience identifying and implementing novel design control framework in a non traditional medical device environment while ensuring compliance to relevant regulations and standards.
- Experience working with and leading multi-functional teams comprising of various engineering fields.
Description
You will ensure that products meet quality goals, and regulatory requirements including but not limited to FDA Quality System Regulations, ISO 13485, EU MDR requirements, and managing risk per ISO 14971 and provide design assurance leadership in activities associated with new product development:
- Advocate for product safety and efficacy.
- Serve as a technical resource for requirements, risk, verification and validation, usability, design transfer, product standards etc.
- Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files.
- Assist in the development and approval of design development plans, protocols, reports, master V&V plans and reports, design transfer and post market surveillance.
- Apply knowledge of Design Control principles to positively influence NPD efforts during the product development cycle.
- Lead risk management activities to develop and maintain Product Risk Management Files.
- Partner with the post-market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product’s lifecycle.
- Collaborate with Quality Systems and multi-functional teams to implement electronic tools for documents management, nonconformance tracking, etc. to promote efficiency and improve effectiveness of the Quality Management Systems (QMS).
- Provide support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
- Support quality improvement initiatives as identified by management and in support of QMS and other regulatory requirements.
- Advocate for product safety and efficacy.
- Serve as a technical resource for requirements, risk, verification and validation, usability, design transfer, product standards etc.
- Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files.
- Assist in the development and approval of design development plans, protocols, reports, master V&V plans and reports, design transfer and post market surveillance.
- Apply knowledge of Design Control principles to positively influence NPD efforts during the product development cycle.
- Lead risk management activities to develop and maintain Product Risk Management Files.
- Partner with the post-market surveillance team to drive improvements for sustaining products and to establish a risk management process throughout a product’s lifecycle.
- Collaborate with Quality Systems and multi-functional teams to implement electronic tools for documents management, nonconformance tracking, etc. to promote efficiency and improve effectiveness of the Quality Management Systems (QMS).
- Provide support for other quality activities and initiatives, quality data collection and trending, internal and external audits, training, authoring procedures, etc.
- Support quality improvement initiatives as identified by management and in support of QMS and other regulatory requirements.
Education & Experience
B.S. ME/EE/BME/CS degree or equivalent in any engineering/science field.
Additional Requirements
- - Experience working on software and hardware products within a quality or regulatory system.
- - Expertise in execution of design controls.
- - Shown background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal guidance.
- - Demonstrated competence in determination of appropriate global regulatory requirements for new products or product changes.
- - Strong organizational and leadership skills.
- - Excellent communication skills, both verbal and written.
Pay & Benefits
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