# Principal Manufacturing Engineer - Implantable Device Unit

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

Canonical page: https://career.thegoodapps.co/jobs/8f4ec61b-64b7-42d1-9db0-7e6b40390583

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

- Employment type: full time
- Seniority: Principal
- Location: Cambridge, MA
- Salary: 159000 – 219000 USD per year

## Summary

This role leads manufacturing strategy and execution for implantable drug delivery systems, working across development and commercialization phases to establish scalable processes and best practices. It suits an experienced medical device engineer who can influence cross-functional decisions, manage external partnerships, and drive innovation within strict regulatory frameworks.

_Our summary, not Biogen's wording._

## Skills named

ISO 13485, Process Validation

## Required

- Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related field
- 10+ years manufacturing engineering experience in medical devices
- Experience with Class III implantable devices or drug delivery systems
- Manufacturing scale-up, process validation, and commercialization experience
- Knowledge of FDA QSR, ISO 13485, and ISO 14971
- Cross-functional team leadership and external partnership management
- Manufacturing technology roadmap development and implementation
- Problem-solving and troubleshooting in multi-component assemblies

Apply on Biogen's site: https://biibhr.wd3.myworkdayjobs.com/en-US/external/job/Cambridge-MA/Principal-Manufacturing-Engineer---Implantable-Device-Unit_REQ23637