Principal Biomedical Engineer
About The Position
MiniMed is seeking an experienced Principal Engineer for its Continuous Glucose Monitoring (CGM) Sensor R&D team. The role provides technical leadership in designing, developing, and commercializing next-generation CGM sensor technologies, including sensor components and wearable adhesive patch systems, with an emphasis on performance, reliability, and manufacturability. The engineer leads technical initiatives and product transitions from concept through high-volume commercial manufacturing, driving Design for Manufacturability and collaborating with cross-functional teams, suppliers, and manufacturing partners to develop robust designs and scalable processes. The role calls for medical device product development experience, preferably involving adhesive systems or wearable medical devices, along with strong technical problem-solving and cross-functional leadership. The successful candidate will have experience transferring complex products into validated, high-volume manufacturing environments. Work may also include biomedical equipment safety testing, repair, maintenance, and regulatory and quality compliance, as well as research into enzyme reactions and organic compounds, compound screening and optimization, and enzyme assay development and execution.
Requirements
- Bachelor’s degree and at least 7 years of relevant experience, or an advanced degree and at least 5 years of relevant experience.
- Strong experience in medical device product development and transferring complex products into validated, high-volume manufacturing environments.
- Strong technical problem-solving skills and cross-functional leadership experience.
- Ability to work on multiple projects in a deadline-driven environment.
Nice To Haves
- Experience developing CGMs, insulin pump adhesives, or wearable skin-contact medical devices within design controls and Quality Management systems.
- Familiarity with ISO 10993 biocompatibility and ISO 13485 design controls.
- Experience leading complex, cross-functional failure analysis investigations using structured methods such as DMAIC, root cause analysis, and hypothesis-driven experimentation.
- Proven ability to lead complex projects with limited oversight, manage priorities, influence cross-functional stakeholders, and coach or mentor engineers.
- Degree in Mechanical Engineering, Biomedical Engineering, or Materials Science.
- Medical device experience.
- Expert proficiency with statistical tools such as Minitab, JMP, or MATLAB for tolerance loop analysis, process capability, and advanced ANOVA testing.
- DMAIC certification or equivalent scientific-method problem-solving certification for root cause analysis.
- Green Belt in DRM or Six Sigma.
- Experience with precision web conversion and multi-layer roll-to-roll manufacturing.
- Experience in process and test method development and validation.
- Hands-on mentality.
Responsibilities
- Lead the design, development, and optimization of CGM sensor components and wearable technologies, including adhesive patch systems.
- Translate Voice of Customer feedback and product needs into technical requirements and engineering solutions.
- Drive product and process development from concept through design verification, validation, and commercial manufacturing transfer.
- Apply Design for Reliability and Manufacturing (DRM), Design for Six Sigma (DFSS), and Design for Manufacturing and Assembly (DFM/A) principles to improve performance, reliability, and manufacturability.
- Design and execute engineering studies to evaluate technologies, optimize processes, troubleshoot technical issues, and identify root causes.
- Lead product improvements and support research, preclinical studies, and investigations related to product performance.
- Collaborate with suppliers and manufacturing partners on material selection, component development, process optimization, and technical challenges.
- Support equipment and tooling development, including design, selection, installation, and qualification for manufacturing processes.
- Use engineering tools and methods, including CAD, GD&T, and tolerance analysis, to support product and process design.
- Provide technical leadership and project coordination across cross-functional teams to meet development milestones and business objectives.
- Prepare technical reports, lead design reviews, and communicate engineering findings and project updates to teams and management.
- Mentor junior engineers, provide technical guidance, and review engineering work for quality and technical rigor.
- Design, develop, and provide safety testing, repair, and maintenance of biomedical equipment.
- Ensure biomedical equipment complies with applicable regulatory requirements and quality control standards.
- Design studies and conduct research on enzyme reactions and the effects of organic compounds on biological processes.
- Participate in compound screening and optimization programs and develop and run enzyme assays.
Benefits
- Competitive salary and flexible benefits package.
- Health insurance.
- Dental insurance.
- Vision insurance.
- Health Savings Account.
- Healthcare Flexible Spending Account.
- Life insurance.
- Long-term disability leave.
- Dependent daycare spending account.
- Incentive plans.
- 401(k) plan with company match.
- Short-term disability coverage.
- Paid time off and holidays.
- Employee Stock Purchase Plan.
- Employee Assistance Program.
- Non-qualified Retirement Plan Supplement for eligible employees.
- Capital Accumulation Plan for eligible employees.
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What This Job Offers
Job Type
Full-time
Career Level
Principal
