Sr. Design Quality Engineer

Apply now: Sr. Design Quality Engineer, location is Hybrid (Danvers, MA). The start date is ASAP for this permanent position.

Job Title: Sr. Design Quality Engineer
Location-Type: Hybrid (Danvers, MA 01923 - minimum 3 days onsite)
Start Date Is: ASAP
Duration: Permanent
Compensation Range: $109,000 - $170k (flex, based on experience) + 12% bonus (prorated)
Benefits: Health, Dental, Vision, 401k, PTO


Job Description:
Join a leading, innovative MedTech organization in the cardiovascular space, supporting life-saving medical devices used globally. This role offers the opportunity to work on cutting-edge, next-generation products while contributing to both new product development and sustaining efforts in a highly collaborative, fast-paced environment.

This role supports both new product development and sustaining quality efforts for complex cardiovascular medical devices. The ideal candidate is hands-on with design control and risk management, able to actively contribute technically while collaborating across teams.

Day-to-Day Responsibilities:

• Support design quality activities across new product development and sustaining projects
• Review and approve design inputs, outputs, and change orders
• Lead and facilitate risk management activities (ISO 14971, DFMEA/FMEA, hazard analysis)
• Participate in verification & validation reviews (plans, protocols, reports)
• Support product cybersecurity risk assessments and planning activities
• Partner with cross-functional teams (Engineering, R&D, Regulatory, Quality)
• Support CAPA activities and quality system improvements
• Assist with audits and ensure compliance with QMS procedures (SOPs)
• Apply problem-solving methodologies to resolve quality issues

Requirements:

Must-Haves:

• Bachelor's degree in Engineering or related scientific field
• 5+ years of experience in a highly regulated industry
• Medical device or biotechnology industry experience
• Strong knowledge of FDA QSR (21 CFR Part 820) and quality standards (ISO 13485, ISO 14971)
• Hands-on experience with design control and risk management
• Experience conducting DFMEA/FMEA and risk management files
• Strong communication skills and ability to work cross-functionally

Nice-to-Haves:

• Experience with electromechanical medical devices
• Familiarity with IEC 62304 and other regulatory standards
• Experience with cybersecurity risk management in medical devices
• Knowledge of statistical analysis and reliability tools
• Advanced degree in engineering or related field