Hardware Design Engineer - Principal at Medtronic in Mounds View, Minnesota

Job Description:

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.

The Principal Hardware Design Engineer for Medtronic CRM Released Product Engineering (RPE) will be responsible for device electrical hardware 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.

A Day in the Life:
•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 New Product Development 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

Must Have: Minimum Requirements

• Bachelors degree required
• Minimum of 7 years of relevant experience, or advanced degree with a minimum of 5 years relevant experience

Nice to Have:
•MS in Electrical or Biomedical Engineering
•Working knowledge of Quality System Regulation (QSR 21 CFR 820), EU Medical Device Directive, and ISO (13485:2003)
•Knowledge of Cardiac Therapy-related 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 status
•Proficient knowledge of medical device industry standards, regulations compliance requirements
•Basic knowledge of device hardware processes, device electrical components, processes, PFMEA and DFMEA
•Demonstrates good judgment pertaining to issue escalation and consultation with other SME's
•Able to work independently and exercise appropriate latitude when addressing abstract, yet to be defined technical issues and problems
•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
•Able to facilitate cross functional group problem solving, decision making, and small projects; including CAPA's
•Able to effectively prioritize and work on multiple assignments in parallel while keeping stakeholders updated
•Knowledge of 6 Sigma (DFSS) principles

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.
This position is eligible for a short-term incentive plan. Learn more about the Medtronic Benefits and Incentive Plans at: benefits.medtronic.com

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