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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.

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Help bring the next generation of life-changing medical technology to patients worldwide.

As an R&D Engineer II within the Released Product Engineering (RPE) and Materials team, you will be part of the Cardiac Implantable Technology Development Center (CI TDC). You will be responsible for Released Product Engineering support for leads, catheters, and accessories of commercialized and recently launched new products, including identifying novel failure modes for returned products and addressing field issues by understanding customer use across the Cardiac Rhythm Management (CRM) products.

A Day in the Life:

You will work closely and collaboratively with Reliability, Regulatory, Operations, and Sourcing colleagues to evaluate and implement post market design, process, and supplier related requests. You’ll perform design processing, where used searches / data mining, design control evidence testing / rationale, and other tasks including but not limited to industry literature searches and reviews to support regulatory renewal submissions, clinical evidence reports, and deficiency responses by providing test and rationale data to regulators. You’ll actively participate in industry standard and regulation reviews for lead, catheter, and accessory product applicability and compliance.

Responsibilities may include the following and other duties may be assigned.

•Assists Regulatory Specialists by providing design, clinical use, and test data and/or rationale to support worldwide regulatory submissions and certification renewals. Resolves questions and deficiencies.

•Identifies, oversees, and may perform testing required to obtain necessary data to support regulatory renewals, submissions, and deficiency response.

•Develop new test methods, including fixture design and data acquisition methods as needed.

•Initiates ECR/ECO’s to modify and maintain design documentation (BOM’s, Specs, drawings).

•Reviews and approves manufacturing process, supplier, and design changes and risk assessments.

•Supports CAPA’s (Corrective & Preventive Actions) & RPI’s (Released Product Investigations).

•Collaborates with Reliability and Manufacturing partners to determine and execute appropriate tests/assessments to evaluate supplier, process, material, design, component, or use-condition changes prior to implementation.

•Assists manufacturing sites with line relay out initiatives, interfacility transfers, and outsourcing.

•Supports cost reduction, supply continuity, and continuous improvement projects.

•Provides problem solving support to manufacturing sites and key suppliers to increase yields, maintain process capability and control, and improve efficiency and cost.

•Collaborates with Reliability, Manufacturing, Materials, R&D, and Safety Engineering to investigate product performance issues/returned product analysis to identify root cause(s) and implement corrective action(s).

•Supports internal and external regulatory compliance audits.

•Provides RPE input to new product development teams and actively participates in new product development to RPE transitions to ensure completion of all deliverables.

Must Have: Minimum Requirements

• Bachelors degree required

• Minimum of 2 years of relevant experience, or advanced degree with 0 years of experience

Nice to Have

· Experience in the Medical Device Industry, specifically with troubleshooting Cardiac Rhythm Management products.

· Experience analyzing returns and complaints from the field to determine root cause and propose technical solutions to a wide range of complex problems. Document and communicate findings.

· Change control process experience.

· Ability to work well under moderate pressure and maintain a positive, service-oriented quality focused attitude.

· Experience working individually, in a group, across functions, and with manufacturing partners and or physician / customer partners.

· Proficient in writing test protocols and test reports.

· Experience in coding, scripting, and/or advanced data analysis methods.

· Experienced with FDA and ISO medical device standards.

· Familiarity with combination products (pharma requirements).

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?page_name=signon&co_num=30601&co_affid=medtronic) .

Medtronic Incentive Plan: This position is eligible for an annual Bonus Program. Learn more about Medtronic Incentive Plan (MIP) here .

Min Salary

80000

Max Salary

120000

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.