Principal Manufacturing Engineer – Implantable Device Unit

Biogen

Principal Manufacturing Engineer driving manufacturing strategies for Class III implantable drug delivery systems at Biogen. Leading continuous improvement and industry engagement for innovative practices.

Posted 6/27/2026full-timeCambridge • Massachusetts • 🇺🇸 United StatesLead💰 $159,000 - $219,000 per yearWebsite

Tech Stack

Tools & technologies

Assembly

About the role

Key responsibilities & impact

Lead end-to-end manufacturing strategy, scale-up, and lifecycle management, ensuring alignment with program and organizational objectives.
Define and implement manufacturing standards, control strategies, and best practices across IDU programs.
Serve as the primary technical authority with contract manufacturers, driving performance and innovation.
Influence cross-functional and organizational decisions, providing SME input to development, quality, regulatory, and supply chain strategies.
Drive manufacturing technology roadmaps, process innovation, and continuous improvement initiatives.
Represent the organization externally through industry engagement and collaboration to bring in leading practices.
Transfer new product designs into scalable and robust manufacturing processes.
Establish inspection strategies, validation plans, and compliance documentation.
Evaluate suppliers, manage contract manufacturers, and optimize supply chain processes.
Select and optimize manufacturing processes, tooling, and assembly approaches.
Approve routine engineering documentation and resolve day-to-day manufacturing issues.

Requirements

What you’ll need

Bachelor’s in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or a closely related discipline.
10+ years of manufacturing engineering experience in medical devices.
Experience with Class III implantable devices and/or drug delivery systems.
Demonstrated experience in manufacturing scale-up, process validation, and commercialization.
Strong knowledge of FDA QSR, ISO 13485, and ISO 14971 requirements.
Experience in leading cross-functional teams and managing external partnerships.
Proficiency in developing and implementing manufacturing technology roadmaps.
Strong problem-solving and troubleshooting skills in multi-component assemblies.

Benefits

Comp & perks

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Short- and Long-Term Disability insurance
A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
Up to 12 company paid holidays + 3 paid days off for Personal Significance
80 hours of sick time per calendar year
Paid Maternity and Parental Leave benefit
401(k) program participation with company matched contributions
Employee stock purchase plan
Tuition reimbursement of up to $10,000 per calendar year
Employee Resource Groups participation

ATS Keywords

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Hard Skills & Tools

manufacturing strategyscale-uplifecycle managementmanufacturing standardscontrol strategiesprocess validationcommercializationinspection strategiesvalidation plansmanufacturing technology roadmaps

Soft Skills

leadershipcross-functional collaborationproblem-solvingtroubleshootinginfluencecommunicationinnovationstrategic thinkingteam managementstakeholder engagement