Sr. Process Development Engineer

Key Responsibilities:

• Lead development and deployment of manufacturing processes.
• Design, develop, and validate manufacturing processes and tooling/fixtures
  (3D CAD).
• Support manufacturability and cost-reduction initiatives for current and next-gen programs.
• Collaborate with cross-functional teams (quality, engineering, operations, etc.).
• Create and maintain device routers, manufacturing procedures, and BOMs.
• Monitor and optimize equipment, processes, and yields.
• Lead non-conformance resolutions and participate in Material Review Boards.
• Mentor junior engineers and technicians.
• Ensure compliance with ISO13485, QSR,
  and medical device requirements.

Qualifications:

• Bachelor's degree in Mechanical, Biomedical, or Materials Science Engineering.
• 5+ years of engineering experience in a manufacturing environment.
• Experience with
  3D CAD (SolidWorks
  preferred).
• Strong background in DOE, SPC, FMEA, GDP, QSR, GD&T, ANOVA
  , and
  statistical tools (Minitab, Excel SPC,
  etc.).
• Project management skills with ability to manage multiple priorities.
• Excellent communication, influencing, and mentoring skills.
• Experience working in an
  ISO13485/GMP
  environment.

Preferred:

• Master's degree in Mechanical, Biomedical, or Materials Science Engineering.
• Continued professional development through associations or certifications.