SARACA · 6 hours ago
Sr. Process Development Engineer
SARACA is a company focused on manufacturing processes, and they are seeking a Sr. Process Development Engineer to lead the development and deployment of manufacturing processes. The role involves designing and validating manufacturing processes, collaborating with cross-functional teams, and ensuring compliance with medical device requirements.
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
Qualification
Required
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
Company
SARACA
SARACA is a global engineering R&D services company with 25+ Fortune 500 customers.
H1B Sponsorship
SARACA has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2022 (5)
Funding
Current Stage
Growth StageCompany data provided by crunchbase