Sr. Design Quality Engineer

Medtronic; Lauderdale Courts (TN); On-site; USD 115,000 - 148,000; Full time

Benefits offered by this job

Health, dental and vision insurance

401(k) plan plus employer contribution

Employee Stock Purchase Plan

Tuition assistance/reimbursement

Simple Steps global well-being program

Job summary

Medtronic seeks a Mechanical/Industrial/Biomedical engineer to design and evaluate medical devices for manufacturability, reliability, and cost. You will apply DMAIC, DRM, and FDA/ISO requirements, develop test methods, and analyze data with Minitab and DOE. Collaborate across functions to ensure lifecycle management and regulatory compliance.

Experience with PPAP, CAPA, QMS, and risk assessment is expected, along with strong problem-solving and project management skills.

Qualifications

• Master's degree in Mechanical, Industrial, or Biomedical Engineering with 2+ years in quality, product or validation engineering.
• Experience with DMAIC, Minitab, DOE, SPC, and FMEA/ISO 14971.
• QMS, GDP, FDA 21 CFR Part 820, ISO 13485, and GDP familiarity; IQ/OQ/PQ, CAPA and RCA.

Responsibilities

• Develop and evaluate designs meeting medical device requirements and optimize for manufacturability.
• Verify design functionality with test methods and specifications per FDA/ISO.
• Apply project mgmt, Lean sigma, DMAIC & DRM methodologies; use MS Project and data analysis tools.
• Collaborate with cross-functional teams to ensure regulatory documentation and lifecycle management.
• Utilize CAPA, QMS, PPAP, CP, PF, MR processes to drive improvement and risk reduction.

Skills

DMAIC methodology

Lean Sigma

Statistical analysis

Education

Master's degree in Mechanical, Industrial, or Biomedical Engineering

Tools

MS Project

Minitab

DOE

Job description

We anticipate the application window for this opening will close on - 25 Nov 2026

Position Description

Develop and evaluate designs which meet defined medical device product requirements and that are optimized for manufacturability, reliability, and overall cost to the business. Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements. Utilize project mgmt. and lean sigma methodologies, including Define, Measure, Analyze, Improve, and Control (DMAIC) & Design for Reliability and Manufacturability (DRM), MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including medical device materials and related processes. Utilize design development, analysis and statistical tools including Minitab, and statistical methods including DOE (Design of Experiments), SPC (Statistical Process Control), Variable Gage R & R (Reliability and Repeatability), ANOVA (analysis of Variance), t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis. Evaluate products and process risks using Failure Mode Effects Analysis (FMEA), utilizing ISO14971. Conduct QMS (Quality Mgmt. System) processes including CTQ (Critical to Quality) identification and leverage knowledge of FDA 21 CFR part 820, ISO 13485 and Good Documentation Practices (GDP). Utilize Lean sigma, including design capability, value stream and process mapping, and 5S. Troubleshoot production and other issues utilizing problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s and Ishikawa (Fishbone). Execute Process Qualification including IQ (Installation Qualification), OQ (operation Qualification) and PQ (Performance Qualification) and perform safely. Leverage Corrective and Preventive actions (CAPA) with use of RCA (Root Cause Analysis) to solve problems, document conditions and create solutions to avoid future problems. Responsible for developing, contributing to, and maintaining Periodic Safety Update Reports (PSURs), Clinical Evaluation Reports (CERs), and Technical Documentation (TD files) in accordance with EU MDR (Medical Device Regulations) requirements. Collaborate with cross functional teams to ensure compliance with global regulatory expectations, support lifecycle mgmt. activities, and maintain up to date clinical, safety, and technical documentation for assigned products. Comply with Production Part Approval Process (PPAP) requirements documentation, including Control Plans (CP), Process Flow (PF), and Material Requirements (MR) for transfer projects. Relocation assistance is not available for this position. #LI-DNI.

Basic Qualifications

Requires a Master’s degree in Mechanical, Industrial, or Biomedical Engineering or related engineering field and 2 years of experience as a quality, product or validation engineer. Must possess at least two (2) years of experience with each of the following: DMAIC methodology; Minitab, DOE, SPC, Variable Gage R & R, ANOVA, t-test, regression analysis, Process Capability, and Confidence & Tolerance interval analysis; Product and Process risk utilizing FMEA and ISO 14971, A3 thinking, PDCA, 5 Why’s, and Ishikawa (Fishbone); QMS process, CTQ identification, FDA 21 CFR Part 820, ISO 13485, and GDP; IQ/OQ/PQ, CAPA and RCA; PSUR, CER and TD files as per EU MDR and global requirements; and PPAP, CP, PF, MR for transfer projects.

Salary

Salary: $115,000 to $147,600 per year

Benefits for 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
• Simple Steps (global well-being program)

Benefits and additional compensation 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)
• 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.

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 95,000+ 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 settingis 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. 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.