Principal Engineer (Medical Devices)

Location: Plymouth, Minnesota, United States; minimum 3 days per week onsite

Salary: $104,000–$156,000 annually, plus potential discretionary bonuses and/or long-term incentives.

Company

hirify.global develops vital organ therapy products and services, with a focus on kidney care, dialysis, digital solutions, and advanced medical therapies.

What you will do

• Lead the design and development of product changes for disposable medical devices within sustaining engineering.
• Schedule, budget, and manage engineering projects with minimal guidance.
• Serve as the technical expert for design change programs involving suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
• Investigate and solve complex engineering problems using risk-based methods, customer-focused approaches, dFMEA, human factors engineering, statistical software, and CAD.
• Create and maintain design history files while coordinating R&D activities with global cross-functional stakeholders.
• Contribute to intellectual property through invention disclosures and patent applications; supervise engineers or technicians as needed.

Requirements

• 5+ years of related experience developing Class II or Class III disposable medical products.
• Bachelor’s degree in Mechanical, Plastics, Biomedical Engineering, or a related field; a master’s degree is preferred.
• Advanced knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, bonding, and sterilization.
• Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Working knowledge of CAD and PDM enterprise software such as Creo or SolidWorks.
• Working knowledge of ANSI/AAMI/ISO 14971 medical device risk management, plus the ability to identify risks, develop mitigations, and coach others.

Culture & Benefits

• Flexible workplace policy with at least 3 days per week onsite to support in-person collaboration.
• Medical, dental, and vision coverage beginning on the first day.
• Life, accident, disability, business travel accident, 401(k), and pooled retirement plan benefits.
• Flexible Spending Accounts, educational assistance, paid holidays, 20–35 days of paid time off based on service, family and medical leave, and paid parental leave.
• Additional commuting, childcare, employee assistance, and employee discount benefits.