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Description
The Health group is looking for a Senior Design Assurance Engineer to lead design assurance efforts for new product development projects.
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 who works closely together to establish relationships across multiple functional teams. We care deeply about getting amazing new products into our customers hands.","responsibilities":"Ensure that products meet quality goals, and regulatory requirements including but not limited to ISO 13485, Quality Management System Regulations, EU MDR requirements, and Risk Management per ISO 14971.
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, etc.
Support Program Management with compliance to Design Controls and Risk Management procedures and delivery of robust Design History Files.
Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation.
Apply knowledge of Design Control principles to positively influence new product development efforts, including establishing, reviewing, and approving design inputs/outputs, Design Verification & Validation.
Lead risk management activities by leading cross-functional teams to develop and maintain Product Risk Management Files (Risk Management Plan & Report, HA, UFMEA, DFMEA, PFMEA, etc.).
Provide guidance as needed to assure country specific compliance to the laws and regulations of the targeted market for distribution.
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.
Preferred Qualifications
Experience working on software products within a quality or regulatory system.
Expertise in execution of design controls.
Proven background in being autonomous and being able to clearly work towards establish goals and initiatives with minimal oversight.
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.
Minimum Qualifications
B.S. ME/EE/BME/CS degree or equivalent in any engineering/science discipline.
8+ years of experience in the medical device, biotechnology or pharmaceutical industry as a Design Assurance/Quality Engineer (SaMD AI/ML experience preferred).
Demonstrated competency in international standards (ISO 13485, ISO 14971, IEC 62304, IEC 60601 and MDD/MDR) and U.S. FDA medical device regulations (21 CFR 820).
Experience identifying and implementing novel design control frameworks in a fast paced medical device environment while ensuring compliance to relevant regulations and standards.
Familiarity with software development practices and technical software development concepts and tools.
Experience working with cross-functional teams comprising of various engineering disciplines.
Strong organizational and management skills.
Excellent communication skills, both verbal and written.
