Medtronic-posted 3 months ago
$140,800 - $211,200/Yr
Full-time • Mid Level
Santa Ana, CA
Miscellaneous Manufacturing

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. The Structural Heart and Aortic integrated operating unit offers minimally invasive approaches to restore proper structure and function of the heart and the aorta. We focus on the transcatheter replacement or repair of the four heart valves—aortic, pulmonic, mitral, tricuspid—and the placement of stent grafts to treat aneurysms and dissections of the body's largest artery, the aorta. This position will primarily support programs in Mitral and Tricuspid therapy areas. In-person exchanges are invaluable to our work. We are working onsite 4 days per week as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

  • Direct, develop, and coordinate the activities of Program/Project Managers in supporting SH&A implant development programs.
  • Develop and monitor schedules, plans, tasks, and priorities, ensuring a streamlined workflow.
  • Oversee and ensure the delivery of all quality-related deliverables throughout the medical device product development lifecycle.
  • Leverage in-depth knowledge of design controls, risk management (ISO 14971), and regulatory standards such as ISO 13485 and FDA 21 CFR Part 820 to guide cross-functional teams.
  • Lead efforts in design verification and validation, ensuring compliance with quality system regulations and readiness for internal and external audits.
  • Drive continuous improvement initiatives, mentor team members on quality best practices, and maintain robust documentation to support product and process excellence.
  • Drive problem-solving sessions, maintaining a sense of urgency and holding team members accountable to commitments.
  • Anticipate and mitigate risks, balancing time, schedule, cost, and quality, while adhering to safety and regulatory standards.
  • Oversee and manage the operational aspects of ongoing projects and serve as liaison between project management and planning, project team, and line management.
  • Assess project issues and develop resolutions to meet productivity, quality, and client-satisfaction goals and objectives.
  • Communicate with stakeholders, obtain stakeholder engagement to ensure the end products or processes will solve the business problems.
  • Monitor documentation maintenance throughout all phases of research and development.
  • Develop, coordinate and conduct technical reliability studies and evaluations of engineering design concepts and design of experiments (DOE) constructs.
  • Compile and analyze performance reports and process control statistics; investigate and analyze relevant variables potentially affecting product and processes.
  • Ensure that corrective measures meet acceptable reliability standards.
  • Analyze preliminary plans and develop reliability engineering programs to achieve company, customer and governmental agency reliability objectives.
  • Requires a Bachelor's Degree and minimum of 5 years relevant experience, or Master's Degree with a minimum of 3 years of relevant experience or PhD with 0 years of relevant experience.
  • Knowledge in product development, project management, and commercialization in the medical device industry.
  • Strong communication and teamwork skills; must possess excellent relationship building skills with direct reports, peers, and senior leaders.
  • Must be able to lead cross-functional discussions; driving towards alignment, decisions, resolutions when necessary.
  • Experience working under regulations of the FDA, notified bodies, and other regulatory agencies for successful commercial launches.
  • Product launch experience working with Global teams.
  • 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
  • Capital Accumulation Plan
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