Principal Manufacturing Engineer - Implantable Device Unit

What You’ll Do
- Lead end-to-end manufacturing strategy, scale-up, and lifecycle management aligned with program/organizational objectives.
- Define and implement manufacturing standards, control strategies, and best practices across IDU programs.
- Serve as primary technical authority with contract manufacturers, driving performance and innovation.
- Provide SME input to development, quality, regulatory, and supply chain strategies.
- Drive manufacturing technology roadmaps, process innovation, and continuous improvement.
- Represent the organization externally to benchmark and bring in leading practices.
- Transfer new product designs into scalable, 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.

Required Skills / Qualifications
- Bachelor’s in Biomedical Engineering, Mechanical Engineering, Manufacturing Engineering, or related discipline.
- 10+ years 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.
- Experience leading cross-functional teams and managing external partnerships.
- Proficiency in developing/implementing manufacturing technology roadmaps.
- Strong problem-solving/troubleshooting skills in multi-component assemblies.