Senior Process Engineer

About the role:
This position is seeking a highly motivated and experienced Senior Process Engineer to work on product and process development to lead the design and commercialization of new technologies. The successful candidate for this position will have strong technical acumen, problem solving skills, and will drive efficient cross-functional collaboration. This position will support top assembly development and utilize agile development approach to accelerate speed to market.

Responsibilities will include:

• Assesses process capabilities, prioritizes process improvement opportunities, and innovates and implements process improvements on multiple and moderately complex processes.
• Applies technical knowledge to innovate, design, and develop processes, procedures, tooling and/or automation.
• Executes the functional deliverables associated with the PDP/TDP, Project Management, and Quality Systems. Product development process technology development process
• Prepares and presents technical data and recommendations at technical reviews.
• Writes validation protocols and reports applicable to new processes.
• Ensures proper documentation is completed to meet quality systems requirements. (e.g., BOM s, Routers, FMEA s, etc.)
• Oversees development builds associated with the project using special work requests.
• Develops qualified production lines.
• Provides Design for Manufacturability (DFM) input to the engineering print package.
• Contributes ideas to or generates 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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