Stark Pharma Solutions Inc
Sr. Process Development Engineer
Stark Pharma Solutions Inc, Saint Paul, Minnesota, United States
Job Title:
Sr. Process Development Engineer
Location:
Dassel, MN
Experience:
5+ years
Industry:
Medical Equipment Manufacturing
About the Role We are seeking a Senior Process Development Engineer passionate about driving innovation, efficiency, and quality in high-precision manufacturing. This role will lead the development and optimization of advanced manufacturing processes that support next-generation medical products.
Key Responsibilities
Lead the design, development, and deployment of new and improved manufacturing processes.
Develop and validate tooling, fixtures, and processes using 3D CAD (SolidWorks preferred).
Drive cost-reduction and manufacturability initiatives for current and upcoming programs.
Collaborate with cross-functional teams across engineering, quality, and operations.
Create and maintain BOMs, device routers, and manufacturing procedures.
Monitor and optimize equipment performance, yields, and process efficiency.
Lead non-conformance investigations and participate in Material Review Board (MRB) activities.
Mentor junior engineers and ensure compliance with ISO 13485, QSR, and other medical device standards.
Qualifications
Bachelor's degree in Mechanical, Biomedical, or Materials Science Engineering.
Minimum 5 years of experience in a manufacturing engineering environment.
Hands‑on experience with 3D CAD (SolidWorks) and statistical tools (Minitab, Excel SPC, etc.).
Strong knowledge of DOE, SPC, FMEA, GD&T, GDP, and QSR.
Excellent communication, project management, and mentoring skills.
Experience working in an ISO 13485/GMP regulated environment.
Preferred Qualifications
Master's degree in Mechanical, Biomedical, or Materials Science Engineering.
Relevant professional certifications and continued professional development.
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Sr. Process Development Engineer
Location:
Dassel, MN
Experience:
5+ years
Industry:
Medical Equipment Manufacturing
About the Role We are seeking a Senior Process Development Engineer passionate about driving innovation, efficiency, and quality in high-precision manufacturing. This role will lead the development and optimization of advanced manufacturing processes that support next-generation medical products.
Key Responsibilities
Lead the design, development, and deployment of new and improved manufacturing processes.
Develop and validate tooling, fixtures, and processes using 3D CAD (SolidWorks preferred).
Drive cost-reduction and manufacturability initiatives for current and upcoming programs.
Collaborate with cross-functional teams across engineering, quality, and operations.
Create and maintain BOMs, device routers, and manufacturing procedures.
Monitor and optimize equipment performance, yields, and process efficiency.
Lead non-conformance investigations and participate in Material Review Board (MRB) activities.
Mentor junior engineers and ensure compliance with ISO 13485, QSR, and other medical device standards.
Qualifications
Bachelor's degree in Mechanical, Biomedical, or Materials Science Engineering.
Minimum 5 years of experience in a manufacturing engineering environment.
Hands‑on experience with 3D CAD (SolidWorks) and statistical tools (Minitab, Excel SPC, etc.).
Strong knowledge of DOE, SPC, FMEA, GD&T, GDP, and QSR.
Excellent communication, project management, and mentoring skills.
Experience working in an ISO 13485/GMP regulated environment.
Preferred Qualifications
Master's degree in Mechanical, Biomedical, or Materials Science Engineering.
Relevant professional certifications and continued professional development.
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