Lead / Principal Manufacturing Engineer - design transfer - R&D to full scale manufacturing
About The Position
This is a rare opportunity to take a pivotal leadership role at the intersection of R&D and manufacturing—where your work will directly shape how groundbreaking products come to life. As a key leader in Design Transfer and Manufacturing Engineering, you will own the transition of cutting-edge products from development into scalable, high-quality production. You’ll be at the forefront of building and optimizing manufacturing capabilities, introducing innovative processes, and ensuring products are designed for reliability, efficiency, and real-world performance. Will require occasional travel up to 10-15%.
Requirements
- 10–15+ years of experience in manufacturing engineering, including complex electro-mechanical and/or opto-mechanical systems (low-to-medium volume preferred)
- Strong background in process development, validation (IQ/OQ/PQ), and statistical methods/DOE
- Proven ability to solve complex problems and make high-level technical decisions
- Experience influencing product design for manufacturability
- Leadership experience, with the ability to guide and mentor engineering teams
- Proficiency with tools such as Word, Excel, Project, and PowerPoint
- Bachelor’s or Master’s degree in Engineering or related field
Nice To Haves
- Experience with disposable or single-use medical devices is a plus
- Six Sigma Black Belt a strong plus
Responsibilities
- Lead the critical design transfer process, bringing advanced products from R&D into full-scale manufacturing
- Develop and implement innovative manufacturing methods, tools, equipment, and processes that improve productivity, quality, and cost efficiency
- Influence product design to enhance manufacturability, reliability, and serviceability from the ground up
- Design and launch robust manufacturing processes for new products, enhancements, and changes—driving toward zero-defect quality
- Own process validation activities (IQ/OQ/PQ) and leverage Design of Experiments (DOE) to optimize performance
- Establish best practices, author manufacturing procedures, and develop Bills of Materials
- Evaluate and justify capital equipment investments to support growth and scalability
- Collaborate cross-functionally with R&D, Quality, and Supply Chain to support prototype builds, pilot production, and full commercialization
- Provide hands-on engineering support to troubleshoot and resolve complex production challenges
- Lead, mentor, and develop a team of Manufacturing Engineers while training technicians and production staff
- Oversee production operations including scheduling, build, test, packaging, sterilization, and distribution coordination
- Ensure full compliance with GMP, FDA regulations, and internal quality standards
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What This Job Offers
Job Type
Full-time
Career Level
Principal
