At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You’ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.

A Day in the Life

Sopport AST Advanced Energy for RPE Quality role.

Careers that Change Lives

In this exciting role as a Principal Quality Engineer, you will have responsibility for providing risk management expertise and best practices for released products and post-market activities within the Advanced 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 and disposable products.

A Day in the Life

Provide comprehensive support to Post Market Development Teams with a focus on Design Quality and Risk Management.

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 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 corrective and preventive actions and audit findings.
• Partners with customers, clinical, and commercial communities to drive product lifecycle management to advance existing or new technology introduction
• Capable of leading cross-functional projects with little or no guidance.
• Can assess and prioritize work, balance focus on current/future needs, and triage urgent issues
• Coordinate activities through the Quality Engineering Manager and report regularly on the progress of activities. 
• Participate in meeting departmental goals and objectives.  
• Documents and actively shares knowledge by mentoring, coaching, and teaching employees and/or customers

Must Have: Minimum Requirements

• Bachelor’s degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have

• Excellent communication and technical writing skills
• Experience in Manufacturing and/or Electro-Mechanical Medical Devices
• Leadership-level domain expertise in a technology discipline within Engineering, Research & Development, or Sustaining existing technology/ products
• 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)
• Understanding of Risk Management in accordance with ISO 14971
• General understanding of Design controls in accordance with ISO 13485
• General understanding of GMP/GDP
• Familiarity with Supplier Qualification activities
• Experience with front room and/or back room compliance audit support
• Familiarity with Statistical analysis (capability, TMV, appropriate sample size determination)
• Ability to interact with cross functional team members across multiple sites to create partnerships
• Proven track record in identifying, evaluating, planning, and executing solutions to complex technical problems across more than one product line, business or geography

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 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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Benefits & Compensation
 

Medtronic offers a competitive Salary and flexible Benefits Package
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.
 

Salary ranges for U.S (excl. PR) locations (USD):$116,000.00 - $174,000.00This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).The base salary range is applicable across the United States, excluding Puerto Rico and specific locations in California. The offered rate complies with federal and local regulations and may vary based on factors such as experience, certification/education, market conditions, and location. Compensation and benefits information pertains solely to candidates hired within the United States (local market compensation and benefits will apply for others).

Medtronic benefits and compensation plans

About Medtronic

We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 90,000+ passionate people. 
We are engineers at heart— putting ambitious ideas to work to generate real solutions for real people. From the R&D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.

Learn more about our business, mission, and our commitment to diversity here.

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.

At Medtronic, most positions are posted on our career site for 3-7 days.