# Senior Device Quality Engineering Lead

Hiring organization: [Biogen](https://career.thegoodapps.co/organizations/biogen)

Canonical page: https://career.thegoodapps.co/jobs/2ecf18e8-3fcf-48e5-9561-0d692dec62d4

Listed on Biogen's own careers site. Applications go to them directly.

- Seniority: Senior
- Location: Cambridge, MA
- Salary: 138000 – 185000 USD per year

## Summary

This senior leadership role focuses on ensuring quality and regulatory compliance for medical devices and combination products throughout their lifecycle. It suits experienced quality engineers who are comfortable guiding cross-functional teams, managing supplier relationships, and driving continuous improvement in highly regulated environments.

_Our summary, not Biogen's wording._

## Skills named

Quality Management Systems, Regulatory Compliance, Risk Management

## Required

- BS in Biomedical/Mechanical Engineering or related technical/scientific discipline
- At least 7 years of medical device and/or combination product industry experience
- Extensive knowledge of design control and risk management
- Strong understanding of medical device regulatory requirements and quality standards
- Excellent communication and collaboration skills
- Proven ability to lead cross-functional teams
- Experience leading continuous improvement initiatives within a Quality Management System
- Familiarity with medical device supplier and testing partner management

Apply on Biogen's site: https://biibhr.wd3.myworkdayjobs.com/en-US/external/job/Cambridge-MA/Senior-Device-Quality-Engineering-Lead_REQ23513