SARACA
Helping Medical Device Companies Accelerate Hiring & Compliance | SARACA Solutions
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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
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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.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Engineering and Information Technology
Referrals increase your chances of interviewing at SARACA by 2x
Get notified about new Senior Process Development Engineer jobs in Dassel, MN.
#J-18808-Ljbffr