Senior Design Quality Engineer, Medical Device Software

Capgemini; Andover (MA); On-site; USD 61,000 - 95,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Retirement plan

Job summary

Executive Senior Design Quality Engineer position in the Greater Boston area (Andover, MA) for a medical device client. On-site, contract for 5 months with ongoing opportunities.

Primary focus on software design controls, risk management, and SDLC compliance across the full lifecycle from concept through post-market activities. Responsibilities include leading DHF/DMR/DHR traceability, CAPA and RCA efforts, and coordination with cross-functional teams to meet regulatory submissions (IDE, PMA, EU

Qualifications

• Experience in FDA-regulated medical device software environments.
• Experience with software design reviews, architecture reviews and SDLC deliverables.
• Strong risk management knowledge (ISO 14971) and software risk controls.

Responsibilities

• Serve as Senior Design Quality Engineer on product development teams, ensuring software design controls across lifecycle phases.
• Establish and maintain DHF, DMR, DHR with traceability from user needs to verification/validation evidence.
• Lead risk management activities and ensure integration of risk controls into design/validation.

Skills

Software quality

SDLC

Risk management

FMEA

CAPA

Root cause analysis

IEC 62304

QMS for software

C/C++/C#

Regulatory submissions

Education

Bachelor's degree in Software/Computer/Systems Engineering or related

Advanced degree preferred

ASQ CQE/CSQE or Six Sigma certs a plus

Job description

Executive Senior Design Quality Engineer position in the Greater Boston area (Andover, MA) for a medical device client. On-site, contract for 5 months with ongoing opportunities.

Primary focus on software design controls, risk management, and SDLC compliance across the full lifecycle from concept through post-market activities. Responsibilities include leading DHF/DMR/DHR traceability, CAPA and RCA efforts, and coordination with cross-functional teams to meet regulatory submissions (IDE, PMA, EU