Principal Engineer - Disposables R&D (Medical Devices)

Location: Hybrid in Plymouth, Minnesota, with a minimum of 3 days per week onsite.

Salary: $108,000–$148,500 annually, with 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 design and development of product changes for disposable medical devices within new product development engineering.
• Schedule, budget, and lead engineering projects with minimal guidance.
• Serve as the technical expert for changes involving products, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
• Investigate and solve complex engineering problems using risk-based and customer-focused approaches, including dFMEA, human factors engineering, statistical software, and CAD.
• Lead the creation and maintenance of design history files and coordinate R&D work with global cross-functional stakeholders.
• Follow design controls, safety rules, company procedures, FDA and international regulations; contribute to invention disclosures and patent applications and may supervise engineers or technicians.

Requirements

• BS in Mechanical, Plastics, Biomedical Engineering, or a related field; MS preferred.
• 5–8+ years of related experience in Class II or Class III disposable medical product development.
• Advanced knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV/solvent bonding, and sterilization.
• Advanced knowledge of FDA Design Controls and ISO 13485 Quality Management Systems.
• Working knowledge of CAD design and PDM enterprise software, such as Creo or SolidWorks.
• Working knowledge of ANSI/AAMI/ISO 14971 medical device risk management.
• Ability to identify technical risks, develop and execute mitigations, and remove or avoid project roadblocks.
• Initiative, aptitude for learning and innovation, continuous-improvement mindset, and ability to manage multiple priorities independently.
• Ability to train and coach others, with strong interpersonal, communication, collaboration, and influencing skills; ability to read, write, and comprehend English.

Culture & Benefits

• Flexible workplace policy with regular in-person collaboration and a minimum of 3 onsite days per week.
• Medical, dental, and vision coverage beginning on day one, plus life, disability, and business travel accident insurance.
• 401(k) retirement savings plan, investment options, financial education, flexible spending accounts, and educational assistance.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Commuting benefits, employee discount, employee assistance, and childcare benefits.