Sr. R&D Engineer

Location: Irvine, California, United States of America

Remote Type: Flexible Work Arrangement

Job Description

Position Description:     

Provide 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 and stent delivery system device design, process development and manufacturing); navigate complex regulations including FDA QSR, CFR 820, ISO13485, ISO14971, IS020417, ISO 15223-1, ASTM F2503 and EU Medical Device Directive; responsible for R&D product Labeling design and development for new product launches, new market expansion, and sustaining products, Supplier activities including part qualifications, Corrective and Preventive action (CAPA), risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis; analyze Post-market surveillance data, investigate and respond to complaints; coordinate Measurement System Analysis, Gage R&R and Test Method validations (TMV); Product Life Cycle Management, utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). #LI-DNI

Basic Qualifications:       

Requires a Master’s degree in Technology Management or Mechanical, Industrial, Biomedical or Electronics Engineering and two (2) years of experience as an R&D engineer, manufacturing engineer, or related occupation in R&D engineering or manufacturing engineering. Must possess at least two (2) years of 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, IS020417, ISO 15223-1, ASTM F2503 and EU Medical Device Directive; R&D product labeling design and development for new product launches, new market expansion, and sustaining products, supplier activities including part qualifications, Corrective and Preventive action (CAPA), risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis and Design Failure Mode Control Analysis; analyzing post-market surveillance, investigating and responding to complaints; Measurement System Analysis, Gage R&R and Test Method validations (TMV); and Product Life Cycle Management, Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP). Position permits a hybrid work model and requires onsite work 4 days/week. Relocation assistance is not available for this position.

Salary: $124,000 to $156,000 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