Medtronic-posted 3 months ago
$140,800 - $211,200/Yr
Full-time • Mid Level
Santa Rosa, CA
5,001-10,000 employees
Professional, Scientific, and Technical Services

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. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We're working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.

  • Responsible for monitoring product performance, complaint investigations, and evaluating quality issues impacting released product
  • Responsible for Design Assurance activities supporting changes to commercial products
  • Mentor team members through technical problem solving including CAPA investigations and triaging issues
  • Provide technical knowledge and input into risk assessments when quality issues are being evaluated
  • Provide front room support during inspections from regulatory agencies (e.g. FDA, FDB, Notified Body)
  • Demonstrate the ability to communicate, influence, and negotiate with internal cross-functional employees, internal leaders at all levels and external customers in the pursuit of product quality improvements and post-market risk management
  • Create strategic plans for driving efficiencies, improving competencies, and developing people to continuously improve function
  • Provide oversight and expertise in design change control and risk management activities
  • Requires a Bachelor's Degree and minimum of 5 years relevant experience, or advanced degree with a minimum of 3 years of relevant experience
  • 7+ years relevant engineering experience with implantable medical products
  • Master's degree in engineering, science, or business
  • Working knowledge of multiple quality disciplines, especially reliability, safety and compliance
  • Quality or reliability engineering experience in product development
  • Knowledge and experience of product development processes and design controls
  • Working knowledge of FDA regulations and ISO standards applicable to implantable medical devices and to drug-device combinations
  • 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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