PD Program Manager
Job
Medtronic
Lafayette, CO (In Person)
$183,500 Salary, Part-Time
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Job Description
We anticipate the application window for this opening will close on - 25 Jun 2026
Position Description:
- PD Program Manager for Medtronic, Inc.
FDA QSR 21 CFR 820, ISO 13485
(Medical Device), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) andEN 62304
(Software Development Life Cycle). Responsible for executing projects and ensuring effective collaboration with team members across different time zones and cultural environments. Utilize Monte Carlo simulations to assess and quantify risks and uncertainties across all phases of the project lifecycle, including design, development, testing, regulatory approval, and production. Conduct changes within the SAP environment, includingSAP S/4HANA, SAP
ECC and HP ALM to drive system enhancements, troubleshoot issues and ensure alignment with business processes. Define, execute, and document validation protocols Installation Qualification, Operational Qualification, Performance Qualification. (IQ/OQ/PQ). Lead the design and development of precision components for Injection Molding, Extrusion, and CNC Machining while conducting tolerance stack-up analysis to ensure dimensional accuracy and reliable performance in complex assemblies. Leverage CAD tools including PTC Creo, Minitab, SolidWorks, and AutoCAD within the design team, promoting best practices for 3D modeling, technical drawings, and design validation. Implement Design of Experiments (DOE), oversee the CAPA process and Non-Conforming Material Report (NCMRs). Responsible for strategic development, design, regulatory compliance, and clinical validation of Cerebrospinal Fluid (CSF) and cranial products, ensuring alignment with market needs, safety standards, and company objectives while collaborating with cross-functional teams to drive innovation and product success. Leverage knowledge from being a certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency. 10% international or domestic to suppliers and users. This is an individual contributor position with no direct reports. Relocation assistance not provided. #LI-DNI.Basic Qualifications:
- Bachelor's degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and five (5) years of experience as a manufacturing engineer or related engineering occupation; OR Master's degree in Mechanical Engineering, Industrial Engineering or Biomedical Engineering or related engineering degree and two (2) years of experience as manufacturing engineer or related engineering occupation.
FDA QSR 21 CFR 820, ISO 13485
(Risk Mgmt.), ISO 10993 (Biocompatibility), IEC 62366 (Usability Engineering), IEC 60601-1 (Electrical Safety), EN 14971 (Risk Mgmt.) andEN 62304
(Software Development Life Cycle); Collaborating with international team members; MS projects using Monte Carlo simulation;SAP S/4HANA, SAP
ECC and HP ALM; IQ, OQ and PQ; Design for Injection Molding, extrusion, CNC machining and Tolerance stack up analysis; PTC Creo, Minitab, Solidworks and Auto CAD; DOE, CAPA and NCMR; and Working with Cerebrospinal Fluid (CSF) products.The following certification is required:
Certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency.Travel requirement:
10% international or domestic to suppliers and users.Salary:
- $163,000 to $204,000 per year The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: Health, Dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, Life insurance, Long-term disability leave, Dependent daycare spending account, Tuition assistance/reimbursement, and Simple Steps (global well-being program).
- We change lives
- We build extraordinary solutions as one team
- . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
- This life-changing career is yours to engineer
- . By bringing your ambitious ideas, unique perspective and contributions, you will… +
- Build
- a better future, amplifying your impact on the causes that matter to you and the world +
- Grow
- a career reflective of your passion and abilities +
- Connect
- to a dynamic and inclusive culture that welcomes the challenge of life-long learning These commitments set our team apart from the rest:
- Experiences that put people first
- . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
- Life-transforming technologies
- . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
- Better outcomes for our world
- . Here, it's about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
- Insight-driven care
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