Bachelor's degree in Mechanical Engineering or related discipline; advanced degree preferred.
8+ years of engineering experience, preferably in medical device or regulated industries.
Proven track record in cost-reduction and value engineering initiatives for released products.
Proficiency with CAD tools, especially SolidWorks, and issue-tracking systems like Jira.
Strong knowledge of various manufacturing processes including injection molding and machining.
Experience with supplier changes and material substitutions in engineering contexts.
Familiarity with ISO standards and FDA requirements around design control.
Responsibilities
Own and execute cost-reduction initiatives for medical device products.
Identify high-impact cost drivers through analysis of BOM and supplier spend.
Lead engineering changes while ensuring compliance with relevant regulatory requirements.
Partner with Supply Chain and Quality to evaluate alternative materials and processes.
Collaborate with design engineers to assess feasibility of cost-reduction proposals.
Perform trade studies to balance cost, quality, risk, and manufacturability.
Track cost savings and communicate progress to leadership.
Benefits
Collaborative work culture with cross-functional engagement.
Opportunities for continuous professional development and training.
Focus on real-world impact and measurable results in engineering initiatives.
Involvement in innovative projects within the medical device field.
Full Job Description
What You Will Do in This Role?
Own and execute cost-reduction initiatives for medical device products, including BOM optimization, material substitutions, design simplification, and supplier changes
Identify high-impact cost drivers through BOM analysis, supplier spend reviews, labor studies, and field repair data
Lead engineering change activities (ECRs/ECOs) via SolidWorks associated with cost reduction while ensuring compliance with ISO, IEC, FDA, and QMS requirements
Partner with Supply Chain, Quality, and Manufacturing to evaluate alternate materials, processes, tooling strategies, and sourcing options
Collaborate with Mechanical and Electrical Design Engineers to assess technical feasibility and risk of proposed cost-down changes
Perform structured trade studies balancing cost, quality, risk, and manufacturability; document decisions and recommendations for leadership review
Support Design for Manufacturing (DFM), Design for Assembly (DFA), and Design for Cost (DFC) improvements on released products
Apply DFMEA, PFMEA, and Root Cause Analysis (RCA) processes to cost and quality improvements
Analyze warranty, service, and repair data to identify recurring cost opportunities and drive corrective actions
Coordinate validation, testing, and phased implementation of cost-driven changes to minimize production and field disruption
Track cost savings, implementation progress, and risk status; clearly communicate results to engineering and operations leadership
What You Will Need for This Role?
Bachelor's degree in Mechanical Engineering or related engineering discipline; advanced degree preferred
8+ years of engineering experience supporting manufactured products; medical device or regulated industry experience strongly preferred
Demonstrated experience leading cost-reduction, value engineering, or design-to-cost initiatives on released products
Proficiency with CAD tools (SolidWorks preferred), PDM systems, BOM management, and issue-tracking tools such as Jira
Strong working knowledge of manufacturing processes such as injection molding, blow molding, machining, sheet metal, welding, wire routing, and assembly
Experience with supplier-facing engineering changes, alternate sourcing, and material/process substitutions
Working knowledge of ISO 13485, ISO 14971, applicable IEC standards, and FDA design control expectations
Ability to perform technical risk assessments and root cause analysis related to cost-driven changes
Strong analytical and financial acumen with the ability to quantify savings and articulate trade-offs
Excellent communication skills with the ability to influence across engineering, operations, and leadership
Agiliti offers a robust suite of benefits for regular, full-time, non-union employees including: health insurance options for Medical, Dental & Vision plans, Short- and Long-Term Disability plans, Flexible Spending Accounts, Health Savings Accounts, Life Insurance Options, Paid Time Off, 401K Saving Plan with employer match, Employee Discounts, Tuition Reimbursement, Daily Pay program, Employee Assistance Program, and wellness programs.
Primary Job Location:
Milwaukee Design Center
Additional Locations (if applicable):
Job Title:
Sr Mechanical Engineer
Company:
Agiliti
Location City:
Wauwatosa
Location State:
Wisconsin
About Agiliti Health, Inc.
Agiliti Health, Inc. is a medical equipment management and services company. It provides a range of services, including equipment rental, maintenance, and repair, as well as clinical engineering and asset management. The company serves hospitals, surgery centers, and other healthcare facilities across the United States. Agiliti Health was founded in 2018 and is headquartered in Minneapolis, Minnesota.