Position Description:

Sr. Quality Engineers-New Product Development for Medtronic, Inc located in Fort Worth, TX. Responsible for translating user requirements into design and manufacturing requirements. Define appropriate reliability requirements for components, sub-systems and products. Identify quality characteristics and validation criteria for components, subassemblies, and finished devices. Apply knowledge of Design Control and Design for Reliability & Manufacturing (DRM) principles to positively influence new product development efforts - including Voice of the Customer. Concept Selection, Requirement Flow, Reliability, Design Verification & Validation, and Process Validations. Navigate the quality systems in a regulated environment to include FDA QSR (Quality System Regulation) 21 CFR 820, ISO 9001, ISO 13485 and ISO 14971. Execute Corrective & Preventive Actions (CAPA), Good Manufacturing Practices (GMP), Root cause analysis (RCA) and problem-solving methodologies. Coordinate risk activities such as creating/updating Risk Analysis Techniques, FMEAs (Failure Mode and Effect Analysis), RMR (Risk Mgmt. Report) and PRA (Product Risk Analysis). Utilize statistical methods like Hypothesis Testing, ANOVA, Six Sigma, Gage Repeatability & Reproducibility (Gage R&R). Develop and execute protocols for design transfer to manufacturing thru Test Method Validation (TMV), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) to determine process capability and appropriate acceptance criteria. Utilize product life cycle systems like Agile MAP, executing non-conformance Material Reports in SAP and using statistical methodologies for data analysis using advanced statistical software like Minitab. Position works a hybrid model and will be onsite in Fort Worth, TX – 3 days per week. Relocation assistance not available for this position. #LI-DNI.

Basic Qualifications:

Master’s degree in Biomedical, Mechanical, Industrial Engineering or related engineering field and two (2) years experience as a quality engineer or related occupation in quality engineering OR Bachelors’ Degree in Biomedical, Mechanical, Industrial Engineering or related engineering field and five (5) years experience as a quality engineer or related occupation in quality engineering.

Must possess two (2) years with a Master’s and five (5) years with a Bachelor’s degree in quality engineering in medical device industry. Must possess at least two (2) years’ experience with each of the following: Concept Selection, Requirement Flow, Reliability, Design Verification & Validation, Process Validations, Design Controls; FDA QSR (Quality System Regulation) 21 CFR 820, ISO 9001, ISO 13485 and ISO 14971; CAPA, GMP, RCA, and DMAIC; RMP, FMEAs, RMR, PRA, Risk Analysis Techniques; Hypothesis Testing, Six Sigma, Gage R&R, and ANOVA; DFM/DRM methodology, TMV, GRR, IQ, OQ, PQ and Process Capability; SAP, Agile MAP, Non-conformance Material Reports and Minitab statistical software. ** Position works a hybrid model and will be onsite in Fort Worth, TX – 3 days per week

Salary: $94,400 to $141,600 per year

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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.

We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.

We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.

This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…

• Build a better future, amplifying your impact on the causes that matter to you and the world

• Grow a career reflective of your passion and abilities

• Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning

These commitments set our team apart from the rest:

Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.

Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.

Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.

Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care

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.

For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.

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