Manager, Product Development Engineering

Asensus APS - Research Triangle Park, NC

Full-time - Senior

Research Triangle Park, NC

About the position

This role will manage the Product Development Engineering Team and will contribute directly to the success of electromechanical systems development, instrumentation development, qualification, and regulatory approval. This role is instrumental in advancing our product portfolio, ensuring compliance with rigorous medical standards, and delivering high-quality, reliable solutions to improve patient care. The ideal candidate brings extensive expertise in product development, engineering management, and regulatory compliance, including FDA and ISO requirements.

Responsibilities

• Oversee and direct the product development process for medical capital electromechanical equipment, guiding projects from concept through commercialization.
• Lead a team of engineers, providing mentorship, direction, and technical expertise to ensure timely and successful product launches.
• Ensure adherence to design controls per FDA requirements and ISO standards, including ISO 13485 and ISO 14971.
• Apply thorough knowledge of IEC standards, specifically ISO 60601-1 and ISO 60601-1-2, with a preference for familiarity with ISO 80601 for specialized medical devices.
• Support the establishment of robust processes for cleaning, reprocessing, and biocompatibility testing to ensure product safety and efficacy.
• Collaborate with Quality, Regulatory, and Manufacturing teams to ensure seamless integration of design controls and risk management.
• Drive the application of risk management processes and procedures across product lifecycles.
• Foster a culture of compliance, innovation, and continuous improvement within the team.
• All other duties as directed.

Requirements

• Bachelor's degree in Mechanical Engineering, Electrical Engineering, or a related field.
• Proven experience (8+ years) in product development within the medical device industry, ideally with capital electromechanical equipment or laparoscopic instrumentation.
• Strong understanding of regulatory requirements and standards for medical devices, including ISO 60601, ISO 80601, and FDA design controls. Direct involvement in regulatory audits for design control is a strong plus.
• Strong knowledge and command over product lifecycle documentation including product development processes, product lifecycle management systems, and product sustaining fundamentals (Complaints, NCMRs, CAPAs, vendor management).
• Demonstrated experience (3+ years) as a team lead or in a management role within product development, with a track record of delivering complex products to market.
• Familiarity with ISO 13485 Quality Management System and ISO 14971 Risk Management for Medical Devices.
• Exceptional problem-solving skills, attention to detail, and ability to work effectively in a fast-paced environment.