Manager Design Assurance - Imperative Care

Job Title: Manager Design Assurance

Location: This position is based in our Campbell, California offices. This position is on-site &  full-time 

Why Imperative Care?

Do you want to make a real impact on patients? Imperative Care is changing the way stroke is treated. As part of our team, you’d be developing breakthroughs that will revolutionize the future of stroke care. Every day, the technologies that we develop at Imperative Care directly impact human lives. Our focus is on the needs of the patient, and they come first in everything we do.

What You’ll Do

Responsible for driving exceptional product quality, safety, design, and reliability through the R&D/Product Development cycle.   This technical position will have direct influence on component, assembly, and final product quality from concept to market release. This role will actively participate and lead a technical team through risk management, design concepts, design specifications, design for quality and manufacturing requirements to ensure design projects meet all applicable quality and regulatory requirements. 

• Work directly with cross functional teams to develop and execute quality engineering activities to meet commercial milestones for new product launches
• Participate in designing and writing plans and protocols for testing of complex medical device products with R&D team
• Review technical problems and departmental procedures and recommends solutions to problems or changes in procedures
• Provide authoritative guidance and leadership on ISO13485, 21 CFR Part 820, ISO 14971 and other external standards as needed.
• Provide direction and leadership to QA staff, including hiring, development, and ongoing performance management of staff
• Takes a leadership role in identifying and negotiating with cross-functional peers to implement solutions for complex quality problems by obtaining alignment
• Interface with Co-developer and Contract Manufacturer as needed for new product development projects
• Plan, formulate and implement the overall Design Assurance Engineering team needs
• Train and mentor engineers and other project team members on best practices in quality engineering and regulatory compliance to external standards

What You’ll Bring

• BS in Engineering or related discipline and 8+ years of related experience; or MS in Engineering with 6+ years of related experience; or equivalent combination of education and work experience in the medical device or related regulated industry
• 2+ years of supervisory experience strongly preferred
• Through applied knowledge of ISO 13485, ISO 14971 standards and 21 CFR Part 820 regulations
• Working knowledge of statistics for R&D, quality, reliability and inspection
• Exceptional working knowledge of Design Controls and Risk Management
• Working knowledge of biocompatibility and sterilization validation is a plus
• Strong analytical and problem-solving skills; strong attention to detail

Employee Benefits include a stake in our collective success with stock options, competitive salaries, a 401k plan, health benefits, generous PTO, and a parental leave program.

Salary Range: $180,000 - 195,000 annually

Please note that the salary information is a general guideline only. Imperative Care considers factors such as scope and responsibilities of the position, candidate's work experience, education/training, key skills, and internal equity, as well as location, market and business considerations when extending an offer. 

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