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Onsite Senior Engineering Program Manager – Quality Core Team Member

at Medtronic

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Posted 6 days ago

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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)

Job title

Senior Engineering Program Manager – Quality Core Team Member

Job type

Full Time

Experience level

Senior

Salary

$168,800 - $253,200 per year

Degree requirement

Bachelor's Degree

Tech skills

PMP

Location requirements

OnsiteBrooklyn ParkUnited States

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