PD Program Manager

Medtronic•Lafayette, CO

About The Position

This role is for a PD Program Manager at Medtronic, Inc., focusing on leading released product management (RPM) and sustainment programs. The manager will provide technical and engineering insights on energy-based products to assess the impact of changes on device function and performance. Key aspects include evaluating design and process impacts for remediation efforts related to field complaints and supplier component changes, and coordinating Voice of Customer (VOC) activities and studies. The position requires ensuring compliance with various government and industry regulations, including FDA QSR 21 CFR 820, ISO 13485, ISO 10993, IEC 62366, IEC 60601-1, EN 14971, and EN 62304. The role involves executing projects, fostering collaboration across international teams, and utilizing Monte Carlo simulations for risk assessment. Responsibilities also include conducting changes within SAP environments (S/4HANA, ECC, HP ALM), defining and documenting validation protocols (IQ/OQ/PQ), and leading the design and development of precision components for various manufacturing processes, including tolerance stack-up analysis. The manager will leverage CAD tools like PTC Creo, Minitab, SolidWorks, and AutoCAD, implement Design of Experiments (DOE), and oversee CAPA and NCMR processes. A significant part of the role involves strategic development, design, regulatory compliance, and clinical validation of Cerebrospinal Fluid (CSF) and cranial products, ensuring alignment with market needs and safety standards. This is an individual contributor position with no direct reports, requiring 10% international or domestic travel.

Requirements

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.
Minimum of 2 years of experience in each of the following: 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.) and EN 62304 (Software Development Life Cycle).
Minimum of 2 years of experience in Collaborating with international team members.
Minimum of 2 years of experience in MS projects using Monte Carlo simulation.
Minimum of 2 years of experience in SAP S/4HANA, SAP ECC and HP ALM.
Minimum of 2 years of experience in IQ, OQ and PQ.
Minimum of 2 years of experience in Design for Injection Molding, extrusion, CNC machining and Tolerance stack up analysis.
Minimum of 2 years of experience in PTC Creo, Minitab, Solidworks and Auto CAD.
Minimum of 2 years of experience in DOE, CAPA and NCMR.
Minimum of 2 years of experience in Working with Cerebrospinal Fluid (CSF) products.
Certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency.

Responsibilities

Lead released product management (RPM)/sustainment programs.
Provide Technical and Engineering insights on energy-based products to assess impact of changes on overall function and performance of devices.
Evaluate design and process impacts for changes incorporated as a part of remediation effort addressing field complaints and supplier component changes.
Coordinate Voice of Customer (VOC) activities and formative and summative studies.
Ensure compliance by navigating and adhering to government and industry regulations including 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.) and EN 62304 (Software Development Life Cycle).
Execute 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, including SAP 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.

Benefits

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
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)
Paid sick time (for temporary employees, as required under applicable state law)