Staff Manufacturing Engineer – Medical Devices & NPI Lead
Resonetics
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Job summary
Resonetics is seeking a Staff Manufacturing Engineer to lead production development and readiness activities for finished medical devices and catheter sub-assemblies. The role focuses on Class 2 and 3 interventional device assemblies and will transfer new products from multi-site Agile & LightSpeed Lab teams.
The engineer will manage process development, drive continuous improvement, and serve as a technical resource across global teams, mentoring junior staff and ensuring quality system
Qualifications
- Typically requires minimum of 8 years of related experience with Bachelor’s degree in technical discipline; or 6 years with Master’s degree; or a PhD with 3 years’ experience; or equivalent experience.
- Expertise with QSR and/or ISO 13485.
- Deep expertise and broad application of lean and six sigma concepts and tools.
Responsibilities
- Identifies, plans, and leads execution of project & manufacturing support initiatives to solve complex problems.
- Guides the successful completion of projects and/or process design and improvements.
- Scopes, plans and leads development, qualification and improvement activities for new and existing manufacturing processes, equipment and test methods.
- Mentors and provides career advice to junior engineers/technicians within a work group/project team.
- Assures safety and regulatory compliance of systems by creating failure/safety reports.
Skills
Education
Job description
Resonetics is seeking a Staff Manufacturing Engineer to lead production development and readiness activities for finished medical devices and catheter sub-assemblies. The role focuses on Class 2 and 3 interventional device assemblies and will transfer new products from multi-site Agile & LightSpeed Lab teams.
The engineer will manage process development, drive continuous improvement, and serve as a technical resource across global teams, mentoring junior staff and ensuring quality system
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