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 The Sr. Mechanical Design Engineer position 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 a prime technical a wide variety of technical projects. Responsibilities may include the following and other duties may be assigned 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 RR, 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 RD 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 deliverables Required knowledge and Experience Bachelors Degree and 4+ years of Mechanical or Biomedical Engineering experience OR Advanced Degree Knowledge of CRM devices (ICD s, IPG s, CRT-D/P, ICM) High proficiency of using internal systems such as MAP Agile, Enovia, CATS, and Documentum Familiarity with CAD systems such as Creo and SolidWorks Basic level understanding of CRM product implant procedures, clinical use conditions, new indications, competitive product landscape state of the art industry status Knowledge of medical device industry standards, regulations compliance requirements Basic knowledge of mechanical processes, materials, processes, PFMEA and DFMEA Demonstrates good judgment pertaining to issue escalation and consultation with other SME s Results focused. Able to deliver consistent, high quality work to meet product performance, compliance, schedule, and budget requirements Able to provide solutions to a variety of technical problems of challenging scope and complexity Possesses working knowledge of statistical and data analysis tools. SPC, DOE, Gauge RR, CpK Demonstrates clear, factual, and effective oral and written communication with variety of cross functional colleagues, technical peers, and senior-level management Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated Excellent time management skills with ability to manage multiple priorities and deliver on time Interpersonal skills including ability to effectively formulate and convey technical and cost/benefit/risk information with peers and senior leaders Strong verbal and written communication skills including ability to articulate complex ideas in easy to understand terms Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003) Knowledge of 6 Sigma (DFSS) principles Able to work well under pressure and maintain positive, engaged, and enthusiastic attitude. 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. 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. This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP). 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 RD 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
