Engineer I - R&D Disposables (hybrid)

Location: Hybrid in Plymouth, Minnesota, United States; minimum of 3 days per week onsite.

Estimated base salary: $76,000–$95,000 annually, with potential discretionary bonuses.

Company

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

What you will do

• Support sustaining engineering and new product development projects for disposable medical devices, including design changes, new features, suppliers, materials, labeling, CAPA/NCR, cost reduction, and remediation.
• Identify, investigate, and solve engineering problems using risk-based and customer-focused approaches, dFMEA, Human Factors Engineering, statistical software, and CAD.
• Create, modify, and maintain design history file documentation, including protocols, reports, design specifications, labeling, and design drawings.
• Support and execute test method validations, product testing, and verification and validation activities.
• Build prototypes and models and may operate machine tools or design and build basic tooling, test fixtures, and assembly equipment.
• Follow design control procedures, safety rules, company policies, FDA requirements, and international regulations and guidance.

Requirements

• Bachelor’s degree in Mechanical, Plastics, Biomedical Engineering, or a related field; an MS is preferred.
• 0–2+ years of related experience in Class II or Class III disposable medical product development.
• Understanding of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV or solvent bonding, and sterilization.
• Working knowledge of CAD design and PDM enterprise software such as Creo or SolidWorks.
• Understanding of FDA Design Controls and ISO 13485 Quality Management Systems.
• Understanding of ANSI/AAMI/ISO 14971 medical-device risk management.
• Ability to take initiative, learn quickly, innovate, and contribute to continuous improvement.
• Strong collaboration, verbal and written communication, attention to detail, organization, and ability to independently manage multiple priorities.
• Ability to read, write, and comprehend English.

Nice to have

• Design for Six Sigma training or certification.

Culture & Benefits

• Flexible workplace policy with regular onsite collaboration.
• Medical, dental, and vision coverage beginning on day one.
• Life, accident, short- and long-term disability, and business travel accident insurance.
• 401(k) retirement savings plan, flexible spending accounts, educational assistance, and commuting benefits.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Employee discount, employee assistance, and childcare benefits.