Engineering Program Manager - Santa Ana, CA
About The Position
At Medtronic, you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world. This role focuses on developing and maintaining Quality functional strategies, plans, and schedules to meet project goals and manage risks. The position represents the voice of quality while directing the development of new concepts from initial design to market release. Key responsibilities include communicating program information to ensure Core Team, Extended Quality Team, and Leadership team engagement and alignment, establishing and maintaining relationships with cross-functional partners, and monitoring documentation maintenance throughout all phases of research and development. The role may also involve developing, evaluating, implementing, and maintaining technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products, and selecting, developing, and evaluating personnel to ensure the efficient operation of the function.
Requirements
- Requires practical knowledge in leading and managing the execution of processes, projects and tactics within the job area.
- Excellent verbal / communication skills.
- Requires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum of 5 years of relevant experience, or advanced degree with a minimum of 3 years of relevant experience.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
- The employee is regularly required to be independently mobile.
- The employee is also required to interact with a computer, and communicate with peers and co-workers.
- Roles below the Principal level require candidates to possess unrestricted U.S. work authorization at the time of hire and for the duration of employment.
Nice To Haves
- Experience with Advanced Project management (PMP preferred)
- Experience in medical device product development or manufacturing
- Experience in Design Assurance or Quality roles
- Skilled in project leadership practices including ability to balance risk, effectively influence diverse teams, and ownership of responsibility for outcomes
- Previous experience with process qualifications
- Previous experience with product impact assessments and CAPAs
- Working knowledge of Lean, Six Sigma, or Design for Reliability and Manufacturing
- Electrical, Computer/Software, or Biomedical Engineering degree.
- Hands on experience in dFMEA, pFMEA, risk analysis and management
- Product development knowledge, including V&V activities and direct V&V strategy development
- Strong leadership skills and ability to work in a team environment
- Possesses strong analytical & problem solving skills
- Excellent judgment and strong critical thinking skills
- Demonstrated ability to build effective relationships across organizations and geographies
- Working knowledge of Quality System Regulations (QSR), design control systems, ISO 13485 and GMP
Responsibilities
- Develops and maintains Quality functional strategies, plans and schedules to meet project goals and manage risks
- Represents the voice of quality while directing the development of new concepts from initial design to market release.
- Communicates key program information to ensure Core Team, Extended Quality Team, and Leadership team engagement and alignment
- Establishes and maintains relationships with cross-functional partners
- Monitors documentation maintenance throughout all phases of research and development.
- May develop, evaluate, implement and maintain technical quality assurance and control systems or reliability systems and standards pertaining to materials, techniques, or company products.
- Selects, develops and evaluates personnel to ensure the efficient operation of the function.
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)
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What This Job Offers
Job Type
Full-time
Career Level
Principal
