What are the responsibilities and job description for the Sr. Process Development Engineer position at SARACA?
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.
Salary : $90,000 - $120,000
