Senior Engineer Manufacturing - Wayne, PA
About The Position
As Senior Engineer Manufacturing, you will provide technical leadership and manufacturing engineering expertise to support process development, scale-up, commercialization, and continuous improvement activities across new and existing product lines at our new PSM regulated facility in Wayne, PA. You will collaborate with cross-functional teams to translate innovative concepts into robust, scalable manufacturing processes while ensuring compliance with quality, regulatory, and safety requirements. dsm-firmenich Biomedical is a market leader in regenerative medicine and biomaterials for medical devices. Our innovative materials and technologies help enable the replacement, repair, enhancement, and regeneration of tissue and organ functions, ultimately improving patient outcomes worldwide.
Requirements
- Minimum 6 years of engineering experience in medical devices or a related regulated manufacturing environment required
- Demonstrated expertise in manufacturing processes, process optimization, scale-up, and commercialization activities; PSM experience and clean room experience a strong plus
- Strong knowledge of engineering and quality methodologies, including statistical analysis, DOE, Lean Six Sigma, and problem-solving tools with ability to operate autonomously
- Experience leading technical projects and collaborating effectively across cross-functional teams
- Bachelor’s or master’s degree in Biomedical, Mechanical, Electrical, Chemical, or Materials Engineering, or a related engineering discipline required
Nice To Haves
- PSM experience and clean room experience a strong plus
Responsibilities
- Lead process development, scale-up, validation, and commercialization activities for new and existing products.
- Drive improvements in manufacturing performance, productivity, quality, reliability, and cost through data-driven engineering solutions.
- Design, develop, and evaluate manufacturing equipment, tooling, automation, and machine systems to support operational excellence.
- Lead cross-functional project teams, providing technical direction, project planning, risk assessment, and progress reporting.
- Support investigations, root cause analysis, change management, and resolution of manufacturing and customer-related quality issues.
- Collaborate with Operations, Quality, Regulatory, R&D, and Commercial teams to ensure successful product implementation and lifecycle management.
Benefits
- Competitive compensation and benefits aligned with market practices.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
