MECHANICAL DESIGN ENGINEER - PRINCIPAL

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 LifeThe Principal Mechanical Design Engineer for Medtronic CRM RPE will be responsible for technical and mechanical design leadership for market-released implantable cardiac devices. This role involves collaboration with cross-functional partners such as reliability, regulatory, operations, and sourcing colleagues to evaluate and implement design changes. Represent the organization as the prime technical contact on contracts and projects.•Interact with personnel on significant technical matters often requiring coordination between organizations•Identifies and oversees testing required to obtain necessary data to support field actions, regulatory renewals, submissions and deficiency responses•Provide critical evaluation of device design when representing design in review of Change Impact Forms (CIF’s) •Initiates change activity (CA) to modify maintain design documentation (BOM’s, Specs, drawings)•Supports CAPA’s (Corrective & Preventive Actions) and RPI’s (Released Product Investigations) including possible CAPA ownership•Provides RPE input to new product development teams •Assists Regulatory Specialists by providing design & clinical use data and rationale to support worldwide regulatory submissions and certification renewals.•Supports IQ/OQ/PQ, DOE’s, SPC, Gauge R&R, Sampling methodologies, Data Analysis, Hypothesis Testing, Modeling/Predictive Analyses, Capability Studies (CpK) and Component Qualifications•Collaborates with reliability and manufacturing personnel to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, or component changes prior to implementation •Collaborates with reliability, manufacturing, materials, and R&D to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s)•Assists manufacturing sites with lean layout initiatives, interfacility transfers and outsourcing•Supports cost reduction and continuous improvement projects•Provides problem solving/trouble shooting support to manufacturing sites and key suppliers to increase yields, maintain process capability, and improve efficiency and cost•Supports internal and external regulatory compliance audits•Actively participates in new product development to RPE transfers; ensures completion of all transfer deliverablesNice to Have:Proficient knowledge of CRM devices (ICD’s, IPG’s, CRT-D/P, ICM)Working level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape & state of the art industry statusProficient knowledge of medical device industry standards, regulations compliance requirementsBasic knowledge of mechanical processes, materials, processes, PFMEA and DFMEADemonstrates good judgment pertaining to issue escalation and consultation with other SME’sAble to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problemsResults focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, and budget requirementsAble to provide solutions to a variety of technical problems of challenging scope and complexityPossesses working knowledge of statistical and data analysis tools. SPC, DOE, Gauge R&R, CpKDemonstrates clear, factual, and effective oral and written communication with variety of cross functional colleagues, technical peers, and senior-level managementAble to facilitate cross functional group problem solving, decision making, and small projects; including CAPA’sAble to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updatedAble to work independently, follow established procedures, and give/receive technical peer reviews of work deliverables for accuracy of technical contentBachelor’s Degree in Mechanical or Biomedical EngineeringSolid leadership and interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leadersStrong verbal and written communication skills including ability to articulate complex ideas in easy to understand termsWorking knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003)Knowledge of 6 Sigma (DFSS) principlesRequires a Baccalaureate degree (or for degrees earned outside of the United States, a degree which satisfies the requirements of 8 C.F.R. § 214.2(h)( 4)(iii)(A) and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.Physical Job RequirementsThe 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 & CompensationMedtronic offers a competitive Salary and flexible Benefits PackageA 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):$122,400.00 - $183,600.00This 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 plansAbout MedtronicWe 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.  SummaryLocation: Minneapolis, Minnesota, United States of AmericaType: Full time