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.
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 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 deliverables
Required knowledge and Experience
Bachelor's 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 R&R, 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.
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.
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.
Learn more about our business, mission, and our commitment to diversity here