We anticipate the application window for this opening will close on - 12 Aug 2025
Position Description:
Sr. Quality Engineer for Covidien, LP (a Medtronic company) located in Irvine, CA. Provide quality engineering support for the successful development of Neurovascular products. Ensure design control requirements are met and products are developed and manufactured in accordance with applicable industry standards, regulatory requirements and customer requirements. Work with vascular devices, embolic coils, stents, catheters, balloons, aspiration devices, coatings and guide wires to ensure quality products. Utilize Statistical analysis tools including DOE (Design of Experiments), SPC (Statistical Process Control), ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis with proficiency in Minitab. Utilize process control tools, statistical sampling, and other analytical techniques to maximize the quality and flow of product through the production line. Coordinate Product and Process risk utilizing Process Failure Mode Effects and Criticality Analysis (PFMECA) and Design Failure Mode Effects and Criticality Analysis (DFMECA). Navigate government and industry standards to include FDA 21CFR part 820, ISO13485, ISO14971, Good Manufacturing Practices (GMP)and Good Documentation Practices (GDP). Provide Process Verification & Validation for product quality, including development and execution of protocols Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) and TMV (Test Method Validations). Coordinate root cause analysis using various quality tools (5 Whys, 6M and Ishikawa (Fishbone) Diagram) for failed product or processes. Participate in CAPA (Corrective and Preventive Actions) and implementation of corrective and preventive actions as necessary. Identify Critical to Quality (CTQ) product features, procedures for Inspecting testing and evaluating the precision, accuracy of products, production equipment and sampling methods as well as interpreting engineering drawing and GD&T (Geometric Dimensioning and Tolerancing). Relocation assistance not provided. #LI-DNI
Basic Qualifications:
Master’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and two (2) years of experience as a quality engineer , manufacturing engineer, or in related occupation in quality or manufacturing engineering. Or, Bachelor’s degree in Biomedical Engineering, Mechanical Engineering, Industrial Engineering, or related field and five (5) years of experience as a quality engineer , manufacturing engineer, or in related occupation in quality or manufacturing engineering. Must possess at least two (2) years’ experience with each of the following: DOE, SPC, ANOVA (Analysis of Variance), t-test, Process Capability, Confidence & Tolerance interval analysis;
Product and Process risk utilizing DFMECA and PFMECA; FDA 21CFR 820, ISO13485, ISO14971 and GDP; Six sigma and lean principles; Process Verification & Validation to include IQ, OQ, PQ and TMV; Root cause analysis using 5 Whys, 6M and Ishikawa (Fishbone) Diagram; CAPA investigation and corrective action implementation; Identifying CTQ product features and sampling methods; Interpreting engineering drawing and GD&T.
Position works a hybrid model and will be onsite in Irvine, CA location – 4/5 days per week. May support 2nd Shift operations 3:30 PM to 12:00 AM. Relocation assistance not provided.
Salary: $130,600 to $145,200 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
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