Staff Design Assurance Quality Engineer- Me/Ee

About The Team:

Join our Quality team at a cutting-edge medical technology startup with FDA approval, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented team, seeking like-minded individuals to join us.

Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together!

This position provides hands-on technical guidance and leadership from a Quality perspective to the team throughout all stages of product development up to and including technology transfer and commercialization. We are looking for someone that is highly motivated and solution-oriented; you must be a self-starter, team builder, and excellent communicator. This is a Full Time Salaried position.

A Day In The Life Of Our Staff NPD Quality Engineer - ME/EE:

Provide hands-on guidance for establishing good product and system design requirements, design specifications, detailed designs, verification and validation activities, and planning documentation. Develop hardware and system-related verification and validation strategy for the R&D organization and ensure the execution of the strategy.

Participate in development activities, including design reviews, requirements analysis and tracing, and configuration management. Serve as a technical resource for risk management activities for hardware and systems in compliance with relevant standards. Develop test plans and test cases based upon the product and component level requirements.

Utilize appropriate quality tools and statistical techniques for data analysis and decision-making. Collaborate with Human Factors experts and R&D to assess device usability throughout design and development. Review and approve V&V system maintenance and track modifications.

Conduct root cause analysis of design issues and implement corrective and preventive actions as necessary. Perform audits of Design History Files and support internal and external audits. Assist Regulatory Affairs with relevant submissions, approvals, requests, and inquiries.

Support field service engineering requests and assess serviceability risks. Collaborate with Project Management Office to define project deliverables and establish project schedules. Work efficiently in a fast-paced environment with minimal supervision.

Maintain compliance with relevant aspects of the Quality Management System. Promote best-practice use of statistical tools and techniques. Engage in other Quality Management System activities as assigned. About You:

Bachelor's degree in Engineering or Technology (Mechanical, Industrial, Electrical, Life Sciences, etc.). Minimum of 8 years of Engineering experience in the medical device field with complex medical devices. Minimum of 3 years of experience in a development QE function.

Familiarity with Design Control and Design History File requirements. Proficiency in Quality Management Systems to meet regulatory requirements. Experience with Risk Management, FMEA, Hazard Analysis, GD&T requirements.

Strong statistical skills for test sample size determination and data analysis. Knowledge of electrical CAD tools and PCBA design workflow. Hands-on experience with laboratory equipment and automated testing.

Experience with Design for Manufacturability, Assembly, and Serviceability principles. Proficiency in Microsoft Office, Google Suite, and relevant software systems. Excellent verbal and written communication skills. Preferred: Certifications such as CQE, CQA(BM), CQM, 6 Sigma, etc.

Workplace Type: Hybrid

Benefits & Perks (For Full Time Employees):

• Competitive Salary

• Comprehensive health insurance including Medical, Dental and Vision+ HSA and FSA options

• Equity & Bonus Program

• Life Insurance (company paid & supplemental) and Disability insurance

• Mental health support through medical insurance programs

• Legal and Pet Insurance

• 12+ paid holidays, 15-20 days of PTO + use-what-you-need sick days

• Paid parental leave

• In-office snacks and beverages

• In-office lunch stipend

• Learning & Development Opportunities: On-demand online training and book reimbursement

• Team building and company organized social and celebration events