Job Description
Job Description
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 – minimum 3 days onsite)
Start Date Is: ASAP
Duration: Permanent
Compensation Range: $109,000 – $170k (flex, based on experience) 12% bonus (prorated)
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