Senior Process Development Engineer
2 days ago
About the Role:
This position is seeking a highly motivated and experienced Senior Process Engineer to lead the design and commercialization of new technologies. The successful candidate will have strong technical acumen, problem-solving skills, and drive efficient cross-functional collaboration. This role will support top assembly development and utilize agile development approach to accelerate speed to market.
Key Responsibilities:
- Assess process capabilities, prioritize process improvement opportunities, and innovate and implement process improvements on multiple and moderately complex processes.
- Apply technical knowledge to innovate, design, and develop processes, procedures, tooling, and/or automation.
- Execute functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems.
- Prepare and present technical data and recommendations at technical reviews.
- Write validation protocols and reports applicable to new processes.
- Ensure proper documentation is completed to meet quality systems requirements.
- Oversee development builds associated with the project using special work requests.
- Develop qualified production lines.
- Provide Design for Manufacturability (DFM) input to the engineering print package.
- Contribute ideas to or generate Intellectual Property submissions.
- May serve as a core team lead or extended team member on new development projects.
- May mentor engineers within the team.
Required Qualifications:
- Bachelor's degree in Mechanical Engineering or Biomedical Engineering or related engineering degree.
- 5+ years of demonstrated process development/improvement activities.
- Demonstrated use of Design for Six Sigma tools (DOE, problem-solving).
- Demonstrated ability to develop processes from concept to production.
Preferred Qualifications:
- Experience in Agile New Product Development.
- Medical device or other regulated industry experience.
- Strong mechanical aptitude. Fixture and equipment design or trouble-shooting experience (CAD experience not required).
- Process Development; equipment validations and process characterization and validation experience.
- Demonstrated understanding and usage of statistics to drive improvements.
- Experience working with plastics, metals, and various joining methods.
- Open to travel for up to 10% of their time.
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