Sr Quality Engineer

Medtronic•Lafayette, CO

1d•Onsite

About The Position

Medtronic is seeking a Senior Risk Management Quality Engineer for the surgical operating unit’s new product development quality team. The role supports development of medical devices by embedding patient safety throughout the product lifecycle. It requires expertise in risk management, product development, design controls, and regulatory compliance in the medical device industry, along with a collaborative, self-starting, inquisitive, and adaptable approach. The position leads risk management activities and contributes to quality-system processes, design verification and validation, regulatory compliance, and product quality. It collaborates with cross-functional teams and helps ensure that design and process documentation, risk assessments, and testing records are complete and traceable. The role is onsite at least four days per week. For office work, the employee is regularly required to be independently mobile, use a computer, and communicate with peers and co-workers. The U.S. base salary range is $98,400–$147,600, excluding Puerto Rico and specified California locations. The position is eligible for the Medtronic Incentive Plan. Benefits vary by eligibility and include health, dental and vision insurance, retirement plans, paid time off, paid holidays, and other programs described in the posting.

Requirements

Bachelor’s degree or higher in engineering or a related technical field.
In-depth knowledge of FDA regulations, ISO 13485, ISO 14971, and other relevant standards.
Strong analytical and problem-solving skills, including the ability to conduct thorough root cause analysis.
Excellent written and verbal communication skills and ability to collaborate with cross-functional teams and present complex information to stakeholders.
Proven leadership and project-management skills, including the ability to lead teams and manage multiple projects simultaneously.
For baccalaureate degrees earned outside the United States, a degree satisfying the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Roles below Principal level require unrestricted U.S. work authorization at the time of hire and throughout employment; the posting states that sponsorship is offered exclusively for Principal-level roles and above.

Nice To Haves

Advanced degree.
Certified Quality Engineer (CQE), Six Sigma Green Belt, or equivalent certification.
AAMI design control certification.
Experience in a regulated engineering field.
Medical device industry experience.
Proficiency in quality management systems, risk management, regulatory compliance, and statistics.
Basic knowledge of human anatomy and physiology and surgical procedures.

Responsibilities

Develop and maintain strategies for risk management activities in collaboration with cross-functional teams to support product quality and patient safety.
Create and maintain the risk management file, including risk management plans and reports, and conduct regular risk reviews.
Lead hazard and risk analyses to identify potential risks and implement risk-control measures.
Lead Design Failure Modes and Effects Analyses (DFMEAs) with project teams to evaluate failure modes and impacts.
Analyze and review product complaints to anticipate and prevent future issues.
Integrate product security measures addressing potential vulnerabilities into the risk management file.
Participate in Process FMEA and User FMEA development and integrate these analyses into the risk management file.
Lead design reviews and maintain the risk management file throughout the product lifecycle.
Develop and manage post-market surveillance plans to monitor product performance and safety in the field.
Lead initial-launch field issue evaluation, including root cause analysis, risk evaluation, and product containment strategy.
Ensure traceability between the risk management file, requirements, and design outputs using a requirements management tool.
Evaluate safety-risk implications of design changes.
Lead and mentor teams developing, implementing, and maintaining quality-system processes and standards.
Collaborate with cross-functional teams to define and implement engineering and statistical processes that support product quality and compliance throughout the product lifecycle.
Ensure compliance with applicable regulatory requirements and standards, including FDA regulations, ISO 14971, ISO 13485, ISO 62304, and FDA Part 820; participate in regulatory audits and inspections.
Oversee design validation and verification activities for user needs and design inputs, including development of test plans, protocols, test methods, and reports.
Ensure accurate and thorough documentation, including test results, risk assessments, and reports.

Benefits

Competitive salary and flexible benefits package.
Short-term incentive through the Medtronic Incentive Plan (MIP).
Health insurance.
Dental insurance.
Vision insurance.
Health Savings Account.
Healthcare Flexible Spending Account.
Life insurance.
Long-term disability leave.
Dependent daycare spending account.
Tuition assistance or reimbursement.
Simple Steps global well-being program.
Incentive plans.
401(k) plan with 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 for Vice Presidents and above, or subject to IRS earning minimums.