Principal Manufacturing Engineer - Implantable Device Unit
About The Position
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. Your primary responsibility will be to drive manufacturing strategies and execution for Class III implantable drug delivery systems. This role is essential in shaping and advancing scalable and compliant manufacturing approaches throughout the product lifecycle, from development through commercialization. As a recognized subject matter expert, you will influence cross-functional decisions, establish best practices, and drive continuous improvement within the organization. You will also lead external engagement with contract manufacturers and industry forums to benchmark and implement leading practices. Your contributions will be pivotal in ensuring the success of our manufacturing processes and aligning them with broader organizational objectives.
Requirements
- 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.
Responsibilities
- 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.
Benefits
- 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
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What This Job Offers
Job Type
Full-time
Career Level
Principal
