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Company

Original Job Post

Medtronic · 3 days ago

R-D Engineer II

Mounds View, MN

Full-time

Onsite

Entry, Mid Level

2+ years exp

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Responsibilities

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.

Qualification

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Relevant ExperienceAdvanced DegreeMedical Device IndustryTroubleshootingRoot Cause AnalysisChange ControlTest Protocol WritingData AnalysisFDA RegulationsISO StandardsCombination ProductsProblem-SolvingCommunicationTeamworkAdaptability

Required

Bachelors degree required

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

Preferred

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)

Benefits

Medtronic Incentive Plan: This position is eligible for an annual Bonus Program.

Company

Medtronic

Glassdoor

3.9

Medtronic develops healthcare technology solutions for various medical conditions.

Founded in 1949

Minneapolis, Minnesota, USA

10,001+ employees

https://www.medtronic.com

H1B Sponsorship

Medtronic has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)

Distribution of Different Job Fields Receiving Sponsorship

Trends of Total Sponsorships

2023 (185)

2022 (337)

2021 (383)

2020 (274)