Design Assurance Engineer - Medical Laser Devices

Kaye/Bassman International; Boston (MA); On-site; USD 90,000 - 120,000; Full time

Job summary

The Design Assurance Engineer at Our client will drive design controls, risk management, and regulatory compliance for Class II electro‑mechanical medical devices. You will collaborate across functions to ensure quality, traceability, and robust verification and validation activities, including software validation and DFMEA/PFMEA.

Candidates should hold a bachelor’s degree in a scientific or engineering field, 3–5 years of relevant experience, and familiarity with FDA QSRs, ISO 13485, ISO 14971,

Qualifications

• Bachelor's degree in a scientific or engineering field.
• 3–5 years of experience with Class II electro‑mechanical medical devices.
• Knowledge of Design Controls and Risk Management practices, FDA QSRs, ISO 13485, ISO 14971, IEC 60601, IEC 62366, IEC 62304.
• Experience coordinating medical device compliance testing with external labs (e.g., TUV, Intertek).
• Proficiency in Microsoft Word and Excel; familiarity with statistical tools is a plus.

Responsibilities

• Conduct design control activities for new and sustaining product development.
• Support risk analyses, including DFMEA/PFMEA.
• Assist design verification/validation activities, including software validation and IQ/OQ/PQ.
• Maintain technical design documentation and DHF/Technical Files.
• Coordinate with third‑party test houses for regulatory testing.
• Assist regulatory with FDA/CE submissions.
• Collaborate with cross‑functional teams to ensure high design and safety standards.

Skills

Design Controls

Risk Management

Regulatory Compliance

FDA QSRs/ISO 13485

Statistical Methods

Education

Bachelor's Degree in scientific or engineering field

Tools

Minitab

Job description

The Design Assurance Engineer at Our client will drive design controls, risk management, and regulatory compliance for Class II electro‑mechanical medical devices. You will collaborate across functions to ensure quality, traceability, and robust verification and validation activities, including software validation and DFMEA/PFMEA.

Candidates should hold a bachelor’s degree in a scientific or engineering field, 3–5 years of relevant experience, and familiarity with FDA QSRs, ISO 13485, ISO 14971,