Senior Reliability Engineer (Medical Devices)

Location: Mounds View, Minnesota, United States; hybrid work model requiring a minimum of 4 days per week on-site

Salary: $107,200–$160,800 per year in U.S. locations excluding Puerto Rico and specific California locations

Company

hirify.global develops healthcare technologies, including implantable devices used to treat abnormal heart rhythms.

What you will do

• Analyze, debug, and recommend design or process changes that improve system and process reliability.
• Support post-market surveillance by analyzing product performance data and summarizing findings.
• Conduct risk analyses and prepare risk assessments, technical reports, and quality-impact documentation.
• Support verification and validation of device system requirements, including traceability and testability.
• Evaluate finished product systems across requirements, design, development, integration, testing, verification, and validation.
• Investigate quality issues with cross-functional partners and support corrective actions.

Requirements

• Bachelor’s degree in Engineering, Science, or a technical discipline and 4+ years of related work experience, or 2+ years of related work experience with an advanced degree.
• For baccalaureate degrees earned outside the United States, a degree meeting 8 C.F.R. § 214.2(h)(4)(iii)(A) requirements is required.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is not offered for roles below Principal level.
• Ability to work on-site at least 4 days per week for in-person collaboration and project activities.
• Regularly perform independent mobility, computer-based work, and communication with peers and co-workers; reasonable accommodations may be available.

Nice to have

• Understanding of CRM products and their clinical use, or clinical field experience using CRM products.
• Experience in reliability engineering, risk management, root-cause investigations, and assessing the risk impact of design changes.
• Experience with 21 CFR 820, ISO 13485, and ISO 14971.
• Ability to evaluate and debug electrical designs, including RF performance.
• Experience designing, verifying, and validating Class III medical devices or similar regulated products.
• Ability to perform data analysis using statistical techniques and reliability tools.

Culture & Benefits

• Full-time regular employment with health, dental, vision, life, disability, retirement, paid time off, and paid holiday benefits.
• Additional benefits may include HSA, healthcare FSA, dependent daycare spending account, tuition assistance, and employee assistance programs.
• Eligible for the hirify.global Incentive Plan and Employee Stock Purchase Plan.
• Work is organized around in-person collaboration and project activities at the Mounds View facility.

Hiring process

• Applications should be submitted through official hirify.global channels.