Sr Quality Engineer
Careers that Change Lives
In this exciting role as a Senior Post-Market Quality Engineer you will have responsibility for developing and implementing best practices in risk management and for providing risk management expertise throughout the product life cycle including development, market release, and post-market activities within the Robotics Surgical Technologies organization. This includes evaluating product issues to ensure patient, user and security risk are assessed, and acting as the lead Design Quality Engineer for Post-Market Design Changes on Capital Hardware.
A Day in the Life
Provide comprehensive support to new product development teams with focus on supplier quality and design transfer activities.
Responsibilities may include the following and other duties may be assigned.
- Collaborate with different departments across the organization to understand and review data to assess the patient/user risk associated with the post market life-cycle phase.
- Conduct health hazard assessments or IIAs for fielded products.
- Conduct Corrections & Removals assessments.
- Collaborate cross functionally to perform bounding/scoping for field actions and assist in field action related regulatory inquiries.
- Assess risks that were not previously identified, as well as potential risks associated with changes in therapy, systems, products, components, manufacturing processes,
- Collaborate with Medical Safety and Complaint Handling to review and analyze field data, discuss the harm severity sources and estimate the probability or harm occurrence.
- Support Complaint trending and Severity trending signal dispositions.
- Maintain risk management file throughout product lifecycle, ensuring the latest knowledge on risk reflected in the risk documentation.
- Actively communicate findings to Quality, Development, and Operations teams and escalates when the risk profile of a medical device adversely changes.
- Assure compliance to organizational procedures, regulatory requirements and industry standards, and timely completion of assigned CAPAs and audit findings.
- Develops, modifies, applies and maintains quality standards and protocol for risk management.
- Makes decisions and proposes solutions based on calculated risks identified through data analysis
- Assist with protocol and implement process validation procedures in accordance with QSR, FDA and international guidelines.
- Capable of leading cross-functional projects with little or no guidance.
- Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities.
- Participate in meeting departmental goals and objectives.
- Mentor or supervise junior engineers.
Must Have: Minimum Requirements
- Bachelor’s degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Must Have: Minimum Requirements
- Bachelors degree required
- Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
Nice to Have
- Working knowledge of medical device products
- Excellent communication and technical writing skills
- Experience in Manufacturing and/or Electro-Mechanical Medical Device risk assessments
- Understand therapy (clinical) performance, product function(s), and product use environments to appropriately and strategically apply technical knowledge, analysis tools and methodologies to understand and quantify residual risks.
- Six-Sigma greenbelt or blackbelt certification
- Working knowledge of Quality System Regulation (QSR 21 CFR 820) and EU Medical Device Directive (EU MDD 93/42 EEC)
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Learn more about our benefits here.
This position is eligible for a short-term incentive plan. Learn more about Medtronic Incentive Plan (MIP) on page 6 here.
The provided base salary range is used nationally (except in certain CA locations). The rate offered is compliant with federal/local regulations and may vary by experience, certification/education, market conditions, location, etc.
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 physical demands described within the Responsibilities 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. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
