Careers that Change Lives:Engineers and Scientists create our market-leading portfolio of innovations. Join us to make a lasting impact. Help bring the next generation of life-changing medical technology to patients worldwide.Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology 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.Join us to make a lasting impact. We believe that when people from different cultures, genders, and points of view come together, innovation is the result, and everyone wins. Medtronic walks the walk, creating an inclusive culture where you can thrive.Help bring the next generation of life-changing medical technology to patients worldwide.Medtronic Cardiac Surgery is looking for a Senior Mechanical Design Engineer to join our R&D Released Product Engineering (RPE) Organization. This role will support commercially released product (sustaining) activities focused on troubleshooting, analyzing, and implementing solutions/modifications within the Cardiopulmonary/Perfusion Systems.Areas of responsibilities will include mechanical design, injection molding design and troubleshooting, design requirements, test requirements and test procedures. Candidates must be able to translate design inputs, write detailed specifications, generate and review design documentation, test specifications and test reports in compliance with design control procedures used within the medical device industry. Candidates must also be willing to work in a fast paced, multi-tasking, team environment.A DAY IN THE LIFEDevelop and evaluate designs which meet defined product requirements and that are optimized for producibility, reliability, and overall cost to the business.Work with cross functional teams to review, assess and implement design input for injection molded components.Ability to troubleshoot design issues, particularly understand injection molding related issues (i.e., process, material, design intent).Responsible for product system design and ensuring that products developed meet both internal and external customer requirements.Conduct or direct the evaluation of designs against defined product requirements and ensure optimization for producibility, reliability, and overall cost to the business. Document and support decisions using engineering analysis and data.Verify the functionality of product design by developing design test methodology and specifications to ensure product designs meet applicable performance requirements.Utilize project management and lean sigma methodologies, including DMAIC and MS Project and adhere to the applicable medical device FDA requirements for design and manufacturing, including ISO 13485:2003 medical device materials, related processes, and GMP (Good Manufacturing Practices).Utilize design development, analysis and statistical tools, to include Creo, Minitab, and statistical methods, including DOE, SPC, Measurement System Analysis, Variable Gage R&R, attribute agreement analysis, ANOVA, t-test, and regression analysis.Interface with suppliers, manufacturing facilities and various internal groups to resolve design and manufacturability issues of new and existing products.Create and communicate project plans, tasks and deliverables, and manage time to meet project deadlines.Lead troubleshooting and problem-solving efforts related to development projects. Support decisions through thorough engineering analysis and data.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:· BS or MS in Mechanical Engineering or equivalent with 4+ years progressive mechanical design experience in a regulated medical industry.· Understanding and experience in injection molding of medical devices, thermoplastic part design, engineering, and testing.· Proven communication skills and ability to lead within a multi-functional team environment.· A demonstrated capacity for solving problems through creative designs.· Working knowledge of risk management analysis including Failure Mode and Effects Analysis (FMEA).· Experience with statistical analysis (Minitab, ANOVA, DOE).· Proven experience with CAD software such as SolidWorks and/or Creo.· Knowledge of FDA and ISO 13485:2003 to manage medical device materials, related processes, and GMP (Good Manufacturing Practices).· Experience using problem solving techniques, including A3 thinking, PDCA (Plan, Do, Check, Act), 5 Why’s, and Ishikawa (Fishbone).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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)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.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 (https://www3.benefitsolver.com/benefits/BenefitSolverView?pagename=signon&conum=30601&coaffid=medtronic) .Medtronic Incentive Plan: This position is eligible for an annual Bonus Program. Learn more about Medtronic Incentive Plan (MIP) here .Min Salary98000Max Salary147000It 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.