Development Quality Engineer
6 - 10 years
Westford, MA
Contract
Onsite
1 month ago
About the role
Position Summary
We are seeking an experienced Sr. Development Quality Engineer to support product development initiatives for Class II medical devices. This role will serve as a key quality representative within cross-functional development teams, ensuring product quality, regulatory compliance, patient safety, and customer satisfaction throughout the product lifecycle.
The ideal candidate will have strong experience in design controls, software quality, risk management, verification/validation activities, and regulated medical device environments .
Key Responsibilities
Required Qualifications
Preferred Qualifications
Interview Process
Additional Information
We are seeking an experienced Sr. Development Quality Engineer to support product development initiatives for Class II medical devices. This role will serve as a key quality representative within cross-functional development teams, ensuring product quality, regulatory compliance, patient safety, and customer satisfaction throughout the product lifecycle.
The ideal candidate will have strong experience in design controls, software quality, risk management, verification/validation activities, and regulated medical device environments .
Key Responsibilities
- Support and lead design control activities throughout product development lifecycle
- Create, review, and maintain risk management files including FMEA
- Review product requirements, specifications, test protocols, and test reports
- Support design verification and validation planning, execution, and issue resolution
- Participate in software, firmware, and usability design reviews
- Maintain Design History File (DHF) documentation
- Support software change management, bug fix assessments, and risk evaluations
- Collaborate with manufacturing teams on process development and qualification activities
- Support supplier qualification, component specifications, and vendor sampling plans
- Participate in internal and external audits
- Ensure compliance with Quality Management Systems, FDA, EU MDR, and applicable regulatory standards
- Work across multiple concurrent new product development projects
Required Qualifications
- Bachelor’s degree in Engineering, Computer Science, Biomedical Engineering, or related technical field
- 2–5 years of experience in Development Quality, Design Quality, or Software Quality Engineering
- Experience in the medical device industry required
- Strong knowledge of Class II medical devices
- Hands-on experience with design controls and product development quality systems
- Experience with risk management / FMEA
- Experience reviewing requirements, verification protocols, validation reports, and technical documentation
- Strong understanding of QMS and regulatory compliance standards
- Excellent communication and technical presentation skills
Preferred Qualifications
- Agile software development lifecycle experience
- CAPA management experience
- Exposure to TestComplete or clinical systems
- Programming knowledge in C / C#
- Human factors / usability engineering experience
- Firmware review experience
- Experience with change management processes
Interview Process
- 1st Round: Video Interview with Hiring Manager
- 2nd Round: Onsite Interview with Hiring Manager and Team
Additional Information
- Fast-moving opportunity with immediate hiring need
- Candidates outside the area may be considered only if willing to relocate and attend onsite interviews at their own expense
Skills
Medical Equipment ManufacturingEngineering