Mechanical Design Engineer II (Cardiac Ablation Solutions)

Location: Mounds View, Minnesota, United States; on-site four days per week with one remote day and less than 10% travel.

Salary: $85,600–$128,400 per year, plus eligibility for a short-term incentive plan.

Company

hirify.global develops healthcare technologies and therapies designed to alleviate pain, restore health, and extend life.

What you will do

• Develop mechanical design improvements for released cardiac ablation products, including changes that improve reliability and scalable manufacturing.
• Support inspection and test plans used for returned-product analysis and participate in test method validation, design verification, and validation.
• Lead complaint and product or process issue investigations with limited supervision using structured root-cause analysis.
• Define and implement corrective actions, including CAPAs, in collaboration with program management, manufacturing, quality, and suppliers.
• Create 3D models, engineering drawings, reports, and technical presentations.
• Coordinate information transfer and technical collaboration with manufacturing sites and cross-functional stakeholders.

Requirements

• Bachelor’s degree in science, technology, engineering, or mathematics and at least 3 years of product design or NPI experience, or an advanced degree with at least 1 year of technical experience.
• Unrestricted U.S. work authorization is required at the time of hire and throughout employment.
• Experience or capability in mechanical product design, complaint investigation, and cross-functional technical collaboration.
• Knowledge of mechanical component manufacturing processes for metals and plastics.
• Ability to work on-site four days per week in Mounds View, Minnesota.

Nice to have

• Experience with CAD tools such as SolidWorks.
• Knowledge of medical device standards including FDA 21 CFR 820, ISO 13485, IEC 60601-1, and ISO 15223-1.
• Experience with product risk management and ISO 14971.
• Experience with issue investigation and CAPAs.

Culture & Benefits

• Purpose-driven work developing medical technologies intended to improve patient outcomes.
• Cross-functional collaboration across engineering, manufacturing, quality, suppliers, and manufacturing sites.
• Health, dental, and vision insurance, health savings and flexible spending accounts, life insurance, and disability coverage.
• Paid time off, paid holidays, 401(k) with employer contribution and match, employee stock purchase plan, and tuition assistance.
• Inclusive workplace with reasonable accommodations for qualified individuals with disabilities.