Sr. Manufacturing Process Engineer

Job Title : Sr. Manufacturing Process Engineer

Location : Dassel, MN

Experience : 5+ years

Industry : Medical Equipment Manufacturing

About the Role :

We are seeking a Senior Manufacturing Process 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 :

Master's degree in Mechanical, Biomedical, or Materials Science Engineering.

Relevant professional certifications and continued professional development.