Technical Program Manager, Partial Dentures
Dandy
Assembly
Principal R&D Engineer
Medtronic
full-time
Posted on:
Origin: • 🇺🇸 United States • California
Visit company websiteSalary
💰 $130,400 - $195,600 per year
Job Level
Lead
Tech Stack
Assembly
About the role
- Sustain commercial diabetes products and processes (insulin pumps, glucose sensors, smart insulin pens).
- Work closely with strategic partners and vendors to support current products and initiate new production projects.
- Lead technical communications with internal and external stakeholders in support of process improvements and design changes.
- Perform product and process development activities, create plans and reports, and route for approvals in an eDMS.
- Lead and perform process characterization, support design verification/testing, and support test method development and Test Method Validation (TMV).
- Understand and lead medical device Design Control process; lead design reviews and ensure on-time completion of Design Control deliverables.
- Perform statistical analysis (DOE, Capability Analysis, GR&R) to support decisions.
- Provide guidance and mentorship to junior engineering staff.
- Apply DRM, DFSS, and DFMA methodologies to designs and processes.
- Help develop specifications, test methodologies, and test equipment; perform calculations, analyses, and engineering testing.
- Equipment selection, tooling and fixture development, procurement, installation and qualification.
- Ensure designs meet product specifications, regulatory requirements, and international standards.
- Support corrective and preventive actions with detailed follow up; provide technical feasibility assessments.
- Travel to vendor locations and manufacturing sites as needed; present technical findings and project status to cross-functional teams and management.
Requirements
- Bachelor’s degree and a minimum of 7 years of relevant experience OR Master's degree with a minimum of 5 years relevant experience OR PhD with 3 years relevant experience.
- Experience in medical device design, process development, and characterization testing.
- Strong background in Design Controls; experience maintaining Design History Files (DHF) and leading Design Reviews (NPI and Design Changes).
- Experience in medical plastics and electromechanical assemblies.
- Background in process qualifications including Test Method Validation (TMV) and Design Verification Testing (DVT).
- Experience performing data analysis using statistical methods and tools (DOE, Capability Analysis, GR&R).
- Knowledge of medical device regulations and quality management systems.
- Experience driving design transfer activities to contract manufacturers and supporting commercial launch.
- Experience with SolidWorks, Minitab, Scientific Molding, GD&T (beneficial).
- Experience providing guidance and mentorship to junior engineering staff.
- Familiarity with Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), and Design for Manufacturing Assembly (DFMA).
- Ability to travel to vendor locations and manufacturing sites as needed.
