Sr. R&D Engineer

We anticipate the application window for this opening will close on - 24 Jun 2025

Position Description:       

Sr. R&D Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Multiple positions available. Responsible for providing R&D and quality engineering support to ensure the successful development of Medtronic Neurovascular devices, design transfers, scale-up and ongoing operational support; work with Design and Quality control of Class II and Class III medical devices (bare-metal or coated stents, stent delivery system device design, process development and manufacturing); navigate complex regulations including FDA QSR, CFR 820, ISO13485, ISO14971 and EU Medical Device Directive; Responsible for Risk analysis activities including health hazard Assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis and CAPA; analyzes Post-market surveillance data, investigate and respond to complaints; Coordinates Measurement System Analysis, Design of Experiments and Statistical Process Control, Process Capability and Sampling Techniques; Responsible for the Development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV); Utilizes Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Position works a hybrid model and will be onsite in Irvine, CA – 3-4 days per week. #LI-DNI

Basic Qualifications:        

Masters’ Degree in Mechanical Engineering, Industrial Engineering, Biomedical Engineering, Electronics Engineering or related engineering field and two (2) years of experience as an R&D  or manufacturing engineer or related occupation in R&D or manufacturing engineering. Must possess at least two (2) years’ experience with each of the following: Product Design, Process Development and Manufacturing and Quality control of Class II and Class III medical devices. FDA QSR, CFR 820, ISO13485, ISO14971 and EU Medical Device Directive. Risk analysis activities including health hazard Assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis and CAPA. Analyzing post-market surveillance, investigating and responding to complaints. Measurement System Analysis, Design of Experiments and Statistical Process Control, Process Capability and Sampling Techniques. Development of Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Gage R&R and Test Method validations (TMV). Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Position works a hybrid model and will be onsite in Irvine, CA – 3-4 days per week.

Salary:  $126,000 to $151,200 per year

#LI-DNI

The following benefits and additional compensation are available to those regular employees who work 20+ hours per week: 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, and Simple Steps (global well-being program).

The following benefits and additional compensation are available to all regular employees: 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), and Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

Regular employees are those who are not temporary, such as interns.  Temporary employees are eligible for paid sick time, as required under applicable state law, and the Employee Stock Purchase Plan. Please note some of the above benefits may not apply to workers in Puerto Rico.

Further details are available at the link below: Medtronic benefits and compensation plans