Sr. Mechanical R&D Engineer at Medtronic

Jacksonville, Florida, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

Bachelor’s degree or equivalent in Mechanical or Biomedical Engineering
Five (5) years of experience as a mechanical design engineer for medical devices or related occupation
At least five (5) years of experience in Product Design and Quality control of Class II and/or Class III medical devices
At least five (5) years of experience with FDA QSR 21 CFR 820, ISO13485, ISO14971, and EU MDD/MDR
At least five (5) years of experience in risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, and Design Failure Mode Control Analysis
At least five (5) years of experience with Ansys, Minitab, and PTC Creo
At least five (5) years of experience with Measurement System Analysis, DOE, SPC, Process Capability, and Sampling Techniques
At least five (5) years of experience with GMP & GDP
At least five (5) years of experience creating engineering drawings for molded, sheet metal, machined, and off the shelf components using GD&T
At least five (5) years of experience performing engineering tolerance stack-ups using risk-based techniques

Responsibilities

Provide R&D engineering support to ensure the successful development of Medtronic ENT (Ear, Nose & Throat) devices, design transfers, scale-up and ongoing operational support
Work with Product Design and Quality control of Class II and Class III medical devices including capital powered equipment and sterile disposable equipment
Navigate complex regulations including FDA Quality Systems Regulations (QSR) 21 CFR 820, ISO13485, ISO14971, and EU Medical Device Directive (MDD)/Medical Device Regulations (MDR)
Perform risk analysis activities including health hazard assessment, Fault Tree Analysis, Process Failure Mode Control Analysis, Design Failure Mode Control Analysis, and Corrective and Preventive Actions (CAPA)
Apply engineering analysis techniques and tools using Ansys, Minitab, CE Tol, and PTC Creo
Coordinate Measurement System Analysis, Design of Experiments (DOE) and Statistical Process Control (SPC), Process Capability and Sampling Techniques
Utilize Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Design cosmetic molded parts
Create engineering drawings for molded, sheet metal, machined, and off the shelf components using Geometric Dimensioning and Tolerancing (GD&T)
Perform Engineering tolerance stack-ups using risk-based techniques and communicate design intent with manufacturers

Skills

Key technologies and capabilities for this role

AnsysMinitabPTC CreoGD&TDOESPCISO13485ISO14971FDA QSR 21 CFR 820Fault Tree AnalysisProcess FMEADesign FMEACAPA

Questions & Answers

Common questions about this position

What is the salary range for the Sr. Mechanical R&D Engineer position?

The salary range is $124,500 to $156,000 per year.

Is this position remote or onsite, and what's the work arrangement?

The position works a hybrid model and requires being onsite in Jacksonville, FL 3-4 days per week.

What are the key skills and experience required for this role?

Requires a Bachelor’s degree in Mechanical or Biomedical Engineering and five years of experience as a mechanical design engineer for medical devices, plus five years in each of: product design and quality control of Class II/III devices, FDA QSR/ISO standards, risk analysis (e.g., Fault Tree Analysis), tools like Ansys/Minitab/PTC Creo, statistical methods (DOE/SPC), GMP/GDP, GD&T drawings, and tolerance stack-ups.

What benefits are offered for this position?

Benefits include health, dental and vision insurance, Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability leave, dependent daycare spending account, tuition assistance/reimbursement, and Simple Steps global well-being program.

What makes a strong candidate for this Sr. Mechanical R&D Engineer role?

A strong candidate will have a Bachelor’s in Mechanical or Biomedical Engineering with exactly five years of experience in mechanical design for medical devices, plus five years each in product design/quality for Class II/III devices, regulatory standards like FDA QSR and ISO13485, risk analysis methods, specific tools like Ansys and PTC Creo, statistical techniques, GMP/GDP, GD&T, and tolerance stack-ups.

Medtronic

Develops and manufactures medical devices and therapies

About Medtronic

Medtronic provides medical technology, services, and solutions to improve patient care. The company develops a variety of medical devices, including pacemakers, insulin pumps, surgical tools, and neurostimulation devices, which help diagnose, prevent, and treat chronic diseases. These products are used by hospitals, clinics, and healthcare professionals around the world. Medtronic stands out from competitors by investing significantly in research and development to create new products and offering additional services like training and patient management programs. The goal of Medtronic is to enhance patient outcomes and lower healthcare costs through its comprehensive range of medical solutions.

Fridley, MinnesotaHeadquarters

1949Year Founded

$3.2MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

Health Savings Account/Flexible Spending Account

Unlimited Paid Time Off

Paid Vacation

Paid Sick Leave

Paid Holidays

401(k) Retirement Plan

401(k) Company Match

Employee Stock Purchase Plan

Employee Assistance Program

Wellness Program

Risks

Emerging competitors like Fire1 threaten Medtronic's heart failure management market share.

Spine biologics market growth may attract new entrants, increasing competition for Medtronic.

Recent IPOs in medtech indicate rising competition, challenging Medtronic's market position.

Differentiation

Medtronic's diverse product range spans cardiovascular, diabetes, neurological, and surgical technologies.

The company invests heavily in R&D to drive innovation in medical devices.

Medtronic offers comprehensive services, including training and technical support, enhancing product value.

Upsides

Exclusive deal with Kuros enhances Medtronic's orthopedic portfolio and market share.

Growing spine biologics market offers expansion opportunities in spinal fusion and regenerative medicine.

Balloon catheters market growth aligns with Medtronic's recent product launches, boosting cardiovascular presence.

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