Sr. Reliability Engineer - 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. A Day in the Life A Day in the Life In general, the following responsibilities apply for the Senior Reliability Engineer. This includes, but is not limited to the following: Owns and maintains periodic safety update reports (PSURs) by collaborating with Medical Safety, Regulatory and Clinical teams for all Aortic products Supports Clinical Evaluation Updates for all Aortic products Supports changes to released products in the field by being the quality reviewer on change orders Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D, supplier quality, Manufacturing on a weekly basis to understand product complaints and assess field trends. Works closely with the customer quality experience management team, Returned Goods Investigation team and Manufacturing to understand product complaints received, update product codes and assist in investigations. Improves existing post market processes and systems to improve team performance and productivity Assists in root cause investigations for CAPAs and NCMRs related to product performance, health risk assessments, product holds, product testing and risk file updates as needed for product failure trends seen in the field Assists in conducting monthly trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required. Prepare appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team and customer quality experience management team. Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business. Supports internal and external audits
Requirements
- Requires Bachelor’s degree in engineering with minimum of 4 years of work experience in Engineering, Science, OR Advanced degree in Engineering, Science, or technical discipline with minimum 2 years of work experience OR Phd with 0 years 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.
- Possess unrestricted U.S. work authorization at the time of hire and for the duration of employment (for roles below Principal level).
Nice To Haves
- Advanced degree in engineering, science, or equivalent technical discipline
- Demonstrated understanding of cardiovascular/implant procedures.
- Experience in a highly regulated industry, preferably medical devices in Quality Engineering
Responsibilities
- Owns and maintains periodic safety update reports (PSURs) by collaborating with Medical Safety, Regulatory and Clinical teams for all Aortic products
- Supports Clinical Evaluation Updates for all Aortic products
- Supports changes to released products in the field by being the quality reviewer on change orders
- Collaborates with cross functional teams like customer quality experience management, clinical affairs, medical safety, R&D, supplier quality, Manufacturing on a weekly basis to understand product complaints and assess field trends.
- Works closely with the customer quality experience management team, Returned Goods Investigation team and Manufacturing to understand product complaints received, update product codes and assist in investigations.
- Improves existing post market processes and systems to improve team performance and productivity
- Assists in root cause investigations for CAPAs and NCMRs related to product performance, health risk assessments, product holds, product testing and risk file updates as needed for product failure trends seen in the field
- Assists in conducting monthly trending of complaint data, evaluates negative trends, assesses risk to released products which aids in determining appropriate field actions and analyzes explants and returned products, as required.
- Prepare appropriate responses to regulatory queries for product registrations and other regulatory submissions by working with the regulatory affairs team and customer quality experience management team.
- Prioritize timely presentation of quality issues and escalate to leadership based on sound engineering, analysis & review for the success of the business.
- Supports internal and external audits
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)
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What This Job Offers
Job Type
Full-time
Career Level
Senior
