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Lead Manufacturing Engineer for Medical Innovations
2 months ago
We are seeking a dynamic individual to spearhead the development and commercialization of cutting-edge medical products designed to address vascular conditions.
Key Responsibilities:
- Initiate and oversee product industrialization initiatives, including the selection of equipment, development of processes, characterization, and validation, with a focus on Design for Manufacturability, Reliability, and Serviceability.
- Drive essential performance metrics such as Cost of Goods, Yield, Output, and Quality throughout the project lifecycle and into commercialization.
- Collaborate with cross-functional teams during all phases of product development to ensure successful program execution, utilizing data-driven decision-making supported by appropriate analytical techniques.
- Support both internal and external manufacturing operations, including site-to-site transfers, design modifications, and new product process development.
- Provide coaching and mentorship to junior engineering staff.
Qualifications:
- Bachelor's degree in Engineering or equivalent experience; a Master's degree is preferred.
- A minimum of 5 years of experience in product/process development within the medical device sector, particularly with stents, catheters, or delivery systems.
- Proven track record in commercializing products in a regulated environment.
- Demonstrated success in managing complex manufacturing or new product development projects, focusing on key metrics such as timelines, quality, capacity, capability, cost, and productivity.
- Strong leadership capabilities, including change management, effective communication, and relationship building within a complex organizational structure.
- Experience with Design for Six Sigma tools, Lean, and Six Sigma methodologies (certification preferred).
- Self-motivated individual capable of driving projects to completion through collaboration.
- Familiarity with design for manufacturing, assembly, and testability, as well as project management and mentoring junior engineers.
- Knowledge of FDA QSR/cGMP and ISO13485 standards to ensure compliance with environmental and quality regulations.
As a part of Philips, a health technology company, you will contribute to our mission of ensuring that every individual has access to quality healthcare. We are committed to diversity and inclusion in our workforce, and we encourage candidates from all backgrounds to apply.
