PD Program Manager

Medtronic•Lafayette, CO

13h•Onsite

About The Position

Medtronic, Inc. is seeking a PD Program Manager to lead released product management (RPM)/sustainment programs. This role involves providing technical and engineering insights on energy-based products, evaluating design and process impacts for changes, coordinating Voice of Customer (VOC) activities and studies, and ensuring regulatory compliance. The position requires executing projects with international collaboration, utilizing Monte Carlo simulations for risk assessment, and conducting changes within SAP environments. Responsibilities include defining and documenting validation protocols (IQ/OQ/PQ), leading the design and development of precision components, and leveraging CAD tools. The role also involves implementing Design of Experiments (DOE), overseeing CAPA and NCMR processes, and managing the strategic development, design, regulatory compliance, and clinical validation of Cerebrospinal Fluid (CSF) and cranial products. The position requires knowledge from being a certified Six Sigma Black Belt and involves travel to suppliers and users.

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 FDA QSR 21 CFR 820.
Minimum of 2 years of experience in ISO 13485 (Risk Mgmt.).
Minimum of 2 years of experience in ISO 10993 (Biocompatibility).
Minimum of 2 years of experience in IEC 62366 (Usability Engineering).
Minimum of 2 years of experience in IEC 60601-1 (Electrical Safety).
Minimum of 2 years of experience in EN 14971 (Risk Mgmt.).
Minimum of 2 years of experience in 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 (25%).
Provide Technical and Engineering insights on energy-based products to assess impact of changes on overall function and performance of devices (15%).
Evaluate design and process impacts for changes incorporated as a part of remediation effort addressing field complaints and supplier component changes (10%).
Coordinate Voice of Customer (VOC) activities and formative and summative studies (10%).
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) (10%).
Responsible for executing projects and ensuring effective collaboration with team members across different time zones and cultural environments (2%).
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 (3%).
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 (5%).
Define, execute, and document validation protocols Installation Qualification, Operational Qualification, Performance Qualification. (IQ/OQ/PQ) (5%).
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 (5%).
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 (2%).
Implement Design of Experiments (DOE), oversee the CAPA process and Non-Conforming Material Report (NCMRs) (3%).
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 (3%).
Leverage knowledge from being a certified six sigma black belt by American Society of Quality (ASQ) or equivalent certifying agency (2%).
Travel 10% international or domestic to suppliers and users.

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)
Medtronic Employee Referral Bonus Program ($1,000)