Technical Program Manager in Ford's Connected Vehicle Software division focusing on product and engineering excellence. Lead cross - functional initiatives and manage complex engineering programs.
About the role
- Lead quality efforts for cardiac surgery product development at Medtronic. Collaborate with cross-functional teams to ensure compliance with regulatory standards.
Responsibilities
- Support quality and reliability efforts for Cardiac Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, and ISO 13485.
- Serve as the Quality Core Team Member; coordinate quality team members and ensure accountability for completing functional work within program deadlines from design concept to design transfer to early commercialization.
- Develop Quality functional strategies, plans, and schedules to meet project goals and manage risks.
- Represent Voice of Quality across all global Quality disciplines.
- Ensure quality requests are defined, implemented, and met (requests flow down) across the project.
- Collaborate with cross-functional teams, including R&D, regulatory affairs, and clinical teams, to ensure alignment on quality and compliance requirements.
- Maintain alignment and manage execution across global Quality disciplines.
- Communicate key program information to ensure Core Team and Quality leadership engagement and alignment.
- Plan and manage program resource allocation and budget.
- Identify quality program risks and implement risk burn down strategies.
- Ensure an effective transfer to global Post-Market Quality functions.
- Review and approve Design History File and other related documentation, including plans, requirements, design, development, test protocols, test reports, verification, and validation.
- Ensure all documentation meets reliability standards and follows QMS processes.
- Develop and review documentation for traceability, testability, and compliance according to standard operating procedures.
- Develop expertise in assigned products and projects, including hands-on time in the engineering lab and participation in product training as assigned.
- Collaborate with R&D, systems engineering, and cross-functional teams to develop, qualify, and implement robust, repeatable, and compliant test method validations that ensure traceability and reliability of results.
- Proactively drive and champion strategic quality, reliability, and safety improvements through execution of the risk management process and DRM initiatives.
- Facilitate the development of the product risk management file.
- Ensure process is compliant to risk management procedures.
- Support hardware and software quality and reliability efforts for Cardiac Surgery products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO 13485.
Requirements
- Bachelor’s degree with a minimum of 7 years of relevant experience in quality or engineering OR an Advanced degree with a minimum of 5 years of relevant experience in quality or engineering.
- A minimum of 2 years of program management experience.
- Experience in two or more of the following functions: Design Assurance Engineering, Reliability Engineering, Post-Market Quality Engineering, Quality Systems, Operations Quality Engineering, Supplier Quality Engineering.
- Working knowledge of multiple quality disciplines, especially reliability, safety, and compliance.
- Master’s degree in engineering or business administration.
- PMP certified.
- Proficient in leading cross-functional teams in a matrixed organization.
- Proficient in product development processes and design controls.
- Experienced practitioner of Design for Reliability and Manufacturability (DRM).
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)
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