Sr. R&D Engineer
Share
Job Location:
Irvine, CA - USA
Yearly Salary:
$ 124000 - 156000
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
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 Masters 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: $124000 to $156000 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 insuranceHealth Savings AccountHealthcare Flexible Spending AccountLife insurance Long-term disability leaveDependent daycare spending accountTuition assistance/reimbursement andSimple 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 matchShort-term disabilityPaid time offPaid holidaysEmployee Stock Purchase PlanEmployee Assistance ProgramNon-qualified Retirement Plan Supplement (subject to IRS earning minimums) andCapital 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
Required Experience:
Senior IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
About Company
About Medtronic Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology can do to help alleviate pain, restore health and extend life. We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an excit ... View more
