Biibhr

Principal Manufacturing Engineer - Implantable Device Unit

Cambridge, MA · Principal

Sponsorship not specified$159k-$219kDetected 26 days ago

Product ManagementSupply ChainMechanical DesignFDA RegulatoryMedical DevicesCollaborationProblem Solving

About the role

As a Principal Manufacturing Engineer, you will be an integral part of the Implantable Device Unit and Device Development and Manufacturing team, within the Product Delivery Solutions organization.
This role is essential in shaping and advancing scalable and compliant manufacturing approaches throughout the product lifecycle, from development through commercialization.
Your contributions will be pivotal in ensuring the success of our manufacturing processes and aligning them with broader organizational objectives.

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.
Drive manufacturing technology roadmaps, process innovation, and continuous improvement initiatives.
Transfer new product designs into scalable and robust manufacturing processes.
Evaluate suppliers, manage contract manufacturers, and optimize supply chain processes.
Select and optimize manufacturing processes, tooling, and assembly approaches.
You thrive in a collaborative environment, working cross-functionally to drive strategic partnerships and continuous improvement.
Your ability to influence decisions and lead technical engagements externally is matched by your commitment to maintaining compliance with stringent regulatory requirements.

You are a strategic thinker with a passion for innovation and excellence in manufacturing.
You have a keen eye for detail and a proactive approach to troubleshooting and optimizing manufacturing processes.
Required Skills:

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.
Job Level: Management
Additional Information
The base compensation range for this role is: $159,000.00-$219,000.00

Medical, Dental, Vision, & Life insurances
Fitness & Wellness programs including a fitness reimbursement
Paid Maternity and Parental Leave benefit
Your extensive experience in the medical device industry, particularly with Class III implantable devices, has equipped you with a deep understanding of complex manufacturing processes.
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)
Employee stock purchase plan
Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Up to 12 company paid holidays + 3 paid days off for Personal Significance
401(k) program participation with company matched contributions
We are a global team with a commitment to excellence, and a pioneering spirit.
As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact.

This listing is sourced directly from Biibhr's careers page and normalized into a canonical job model.