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Lead Process Development Engineer
2 months ago
Position Summary:
This position is designed for a seasoned engineer to spearhead innovative technology advancements within the Process Development Team. The ideal candidate will possess robust technical expertise, influence product architecture, and foster effective collaboration across various functions.
Key Responsibilities:
- Evaluate process capabilities, prioritize enhancement opportunities, and innovate on complex project improvements.
- Deliver functional outputs aligned with the Product Development Process (PDP), Project Management, and Quality Assurance Systems.
- Act as a pivotal resource or authority, contributing to the technical strategy for the department and organization.
- Analyze and evaluate processes for potential patentable innovations.
- Ensure transparency and resolution of process challenges (e.g., yields, costs, capabilities) in accordance with PDP timelines.
- Contribute significantly to technical assessments and reviews.
- Investigate external technologies and strategically pinpoint opportunities for internal application.
- Provide continuous mentorship and technical support to managers, engineers, technicians, and other functional teams.
- Mentor junior technicians and engineers.
- Serve as a core team member or subject matter expert on platform and intricate projects.
- May act as a representative or liaison to other locations or external entities, boards, or committees.
Essential Qualifications:
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, or a related engineering discipline.
- Over 7 years of proven experience in process development and enhancement initiatives.
- Proficient in Design for Six Sigma methodologies (DOE, problem-solving, process enhancement).
- Demonstrated capability to transition processes from conception to production.
- Strong mechanical skills, including fixture and equipment design or troubleshooting experience.
Desirable Qualifications:
- Experience in Design for Automation or Design for Manufacturing.
- Background in thermoplastic molding or extrusion.
- Six Sigma Black Belt certification.
- Experience in the medical device sector or other regulated industries.
- Experience in process development, equipment validation, and process characterization and validation.
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