Senior Lead Systems Engineer - Medical Devices (Coagulation)

Werfenlife SA.; Bedford (MA); On-site; USD 160,000 - 190,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401k with employer match

Paid vacation & sick leave

Job summary

Werfen is seeking a Senior Engineering Group Lead in Bedford, MA to serve as a player-coach for Class II/III coagulation programs. You will own design controls, product reliability, and a five-person systems engineering team, while guiding requirements, risk, and verification from design input to output.

The role requires FDA-regulated device experience, a strong leadership presence, and collaboration across mechanical, electrical, software, quality, regulatory, and project management teams.

Qualifications

• Bachelor’s degree in Electrical, Systems, Biomedical Engineering or related discipline.
• 15 years of relevant engineering experience; 10 years with advanced degree.
• Experience with FDA-regulated Class II and/or Class III medical devices.

Responsibilities

• Lead design inputs/outputs for Class II/III medical devices, including requirements management, risk management, V&V, and traceability.
• Own product reliability strategy across the product lifecycle.
• Lead system integration, verification, and validation strategies and develop plans/documents.

Skills

Leadership

Requirement management

Risk management

System integration

V&V

FDA regulations

Waterfall

Agile

DOORS

Communication

Education

Electrical Eng

Systems Eng

Biomedical Eng

Tools

DOORS

Job description

Werfen is seeking a Senior Engineering Group Lead in Bedford, MA to serve as a player-coach for Class II/III coagulation programs. You will own design controls, product reliability, and a five-person systems engineering team, while guiding requirements, risk, and verification from design input to output.

The role requires FDA-regulated device experience, a strong leadership presence, and collaboration across mechanical, electrical, software, quality, regulatory, and project management teams.