Development Engineer
Development Engineer
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Salary Not Disclosed
1 Vacancy
Job Description
Medical Devices Component Development Project Management
Join a highly specialized team working on cutting-edge medical device development and manufacturing excellence. Were looking for a skilled Development Engineer with deep expertise in component qualification cost reduction strategies and plant transfer processes.
Responsibilities:
- Drive design development and qualification of metallic and plastic medical device components.
- Lead project management and cross-functional coordination for development & commissioning effort.
- Perform statistical analysis MSA DOE and implement PPAP-based component qualification.
- Execute risk management including FMEA process validation and GMP compliance
Manage plant transfer and cost optimization through process innovation (not just supplier shifts). - Collaborate on product design with DFMA principles to reduce complexity and improve manufacturability.
- Conduct change management activities for multiple projects in parallel.
Interface with engineering manufacturing and supply chain to ensure seamless execution.
- 6 8 years in medical device or related regulated industry.
- Hands-on experience with.
- Component manufacturing technologies CNC MIM fine blanking welding 3D printing plastic injection melding.
- Process Validation GMP compliance and Design of Experiments (DOE)
GD&T DFMA SPC MSA Gage R&R. - Strong experience in Project Management commissioning and documentation.
- Excellent communication cross-functional leadership and stakeholder alignment.
- Experience with cost-reduction programs through engineering/process improvements.
- Prior involvement in plant transfer activities or new line commissioning.
- Knowledge of regulatory requirements in the medical device industry (FDA ISO).
Employment Type
Full Time
