Reliability Engineer I (Medical Devices)

TL;DR

Reliability Engineer I (Medical Devices): Supporting Post Market Surveillance, Risk Management, and complaint investigations for Cardiac Surgery products with an accent on product reliability and compliance. Focus on executing test method validations, writing Issue Impact Assessments, and ensuring adherence to medical device regulations.

Location: Must be based in or able to work on-site 4 days per week in Mounds View, MN, USA

Salary: $69,600 - $104,400 USD

Company

Global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through medical innovation.

What you will do

• Conduct risk assessments to investigate and confirm the impact of quality issues on field products.
• Support complaint investigations and review event coding to capture findings and field signals.
• Execute test method validations and perform post-market Risk Management deliverables.
• Develop Issue Impact Assessments (IIAs), Complaint Trending, and Periodic Safety Update Reports (PSURs).
• Provide support for continuous improvement projects, Field Corrective Actions (FCAs), and Product Hold Orders (PHOs).
• Collaborate cross-functionally with Quality, Regulatory, and Manufacturing teams to address compliance and supplier non-conformities.

Requirements

• Bachelor’s degree in science, technology, engineering, math, or a related technical discipline.
• Unrestricted U.S. work authorization required at the time of hire and for the duration of employment.

Nice to have

• Quality experience working in the Medical Device Industry.
• Familiarity with FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 10012, and ISO 17025.
• Strong written and verbal communication skills with the ability to work cooperatively in a team.
• Ability to manage multiple projects and timelines effectively.
• Proficiency in Microsoft Office Applications and Windows OS.

Culture & Benefits

• Comprehensive healthcare package including health, dental, and vision insurance, HSA, and FSA.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and access to a global well-being program.
• Competitive base salary and eligibility for the hirify.global Incentive Plan (MIP).