Senior Electrical Engineer (Medical Devices)

Location: Mounds View, Minnesota, United States; minimum 4 days per week on-site with up to 10% travel.

Salary: $108,000–$162,000 per year.

Company

hirify.global develops healthcare technologies, including devices and therapies for abnormal heart rhythms and heart failure.

What you will do

• Collaborate with cross-functional teams to develop and release cardiac rhythm management products and design changes.
• Plan, lead, and integrate Design for Reliability activities to improve product safety, reliability, quality, and complaint reduction.
• Evaluate failure modes, hazards, harms, safety risks, risk controls, and benefit-risk evidence.
• Define reliability requirements, lead reliability demonstration and growth activities, and recommend design and manufacturing updates.
• Develop test plans, determine statistically valid sample sizes, coordinate laboratory testing, analyze data, and write test reports.
• Document reliability and risk management activities for regulatory submissions and audits, review quality records, and advocate for safety and quality in design reviews.

Requirements

• Bachelor’s degree in Science, Technology, Engineering, Math, or a related technical discipline and at least 4 years of experience, or a Master’s degree and at least 2 years of technical experience.
• For baccalaureate degrees earned outside the United States, a degree meeting the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment.

Nice to have

• Experience applying Six Sigma development methods, including Design of Experiments, Robust Characterization, and Capability Analysis.
• Strong circuit analysis and hands-on electrical testing experience.
• Design verification and troubleshooting experience, with working knowledge of quality and statistical methods.
• Experience writing engineering documents such as test plans and reports.
• Medical device or other regulated-industry experience.
• Familiarity with FDA 21 CFR Part 820 cGMP, ISO 13485, ISO 14971, and ISO 5841-2.
• ASQ CRE certification.

Culture & Benefits

• On-site collaboration and cross-functional partnership at the Mounds View facility.
• Health, dental, and vision insurance, health savings and flexible spending accounts, life insurance, and disability coverage.
• Paid time off, paid holidays, retirement plans with employer contribution and match, and an employee stock purchase plan.
• Tuition assistance or reimbursement, dependent daycare spending account, employee assistance, and a global well-being program.
• Eligibility for the hirify.global Incentive Plan and other incentive programs.