Principal Quality Engineer

Principal Design Quality Engineer

18000DOM

Carlsbad, CA

Careers that Change Lives

This position will work in collaboration with others to ensure design quality assurance, R&D regulations and consistent best practices in Risk Management.

A Day in the Life

The Principal Quality Engineer- Risk Specialist will develop and manage the process that establishes and maintains quality assurance and regulatory programs, policies, processes, procedures and controls to ensure that the performance and quality of products conform to established standards and agency guidelines.

• Strong familiarity with regulatory requirements (e.g. ISO 13485,CFR 820 & EN ISO 14971)

• Familiarity with EN ISO 60601-1, EN ISO 60601-1-8, EN ISO 80601-2-12 a distinct advantage.

• Experience in risk evaluation techniques, e.g. HHE/HHA, Product Risk Assessment, SFMEA/HHA, DFMEA, PFMEA & fault tree analysis.

• Familiarity with Hardware EE Design & Development: Design Margin, Component Derating, Creep & Clearance, In Circuit Test, IPC, IEC 61000, Design of Experiments & Reliability Analysis.

• Familiarity with Hardware ME Design & Development: Stack Up and Tolerance Analysis, Key Inspections Analysis Material Analysis, Design of Experiments & Reliability Analysis.

• ASQ CQE, CRE, CSQE certification desirable, but not essential.

• Review new and modified product designs for quality characteristics, including manufacturability, serviceability, testability, reliability, and product requirements.

• Ensure that product development projects and changes to existing products are conducted in compliance with the FDA Quality System Regulations Design phases.

• Participate on cross-functional teams to review marketing requirements and to develop concise, unambiguous, con-conflicting and feasible product requirements that support the market needs.

• Participate on cross-functional teams to develop product risk management file (risk management plan, risk assessments, DFMEA, and risk management report).

• Assist in the creation of verification and validation test plans. Oversee testing and analysis for standards and product requirements compliance.

• Provide guidance and direction for sample size and statistical analysis of verification and validation test results. Experience Statistics stools experience an advantage e.g. Minitab.

• Provide training to project teams on procedures, verification, validation, statistical methods and design controls.

Create a risk management plan, perform product risk assessment, facilitate the failure mode effects analysis, and create a final risk management report.

• Review Design History Files and Technical Files for conformance to applicable requirements.

• Assist, when appropriate with internal and supplier audits.

• Provide Quality support to facilitate the rapid resolution of product complaints and/or safety issues.

• Support the Regulatory Department in writing technical submissions.

Must Have: Minimum Requirements

To be considered for this role, please ensure the minimum requirements are evident on your resume.

• Bachelors Degree in Engineering or Science field with 8+ years relevant experience, or Masters Degree in Engineering or Science field with 6+ years relevant experience.

• Good verbal and written communication skills including protocol / report development and technical presentations.

• Experience in 21CFR820, ISO13485, ISO 14971, CMDR and Medical Device Directive

• Risk Management, ISO 14971, FTA, FMEA, HACCP.

• Comparative Statistical techniques, sampling plans, GR&R, K-factor, hypothesis testing and ANOVA.

• Test plan development and root cause failure analysis.

Nice to Have:

• Previous experience working in a cross-functional team environment.

• Familiar with reliability principles and tools

• ASQ CQE, CQA, CSQE and/or CRE certification.

• Familiar with statistical software tools (Minitab, Stat Graphics, Statistical),

• Familiar with IEC 60601 and product specific industry standards.

• DFSS / Lean Green Belt or Black Belt

About Medtronic

Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services 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 exciting and rewarding place to be.

We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team. Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the future.

Physical Job Requirements

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.

The physical demands described within the Day in the Life section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Up to 10% Travel

EEO

It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.

This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here: