Sr. Engineer – Disposables R&D, NPD (Hybrid)

Location: Plymouth, Minnesota, United States; hybrid with a minimum of 3 days per week onsite

Salary: $88,000–$121,000 annually, with potential eligibility for discretionary bonuses.

Company

hirify.global develops vital organ therapy products and services, with a focus on improving kidney care, dialysis experiences, and patient outcomes.

What you will do

• Support or lead global cross-functional projects for new disposable medical products and product extensions.
• Develop user needs and translate them into product requirements.
• Identify, investigate, and solve engineering problems using risk-based and customer-focused approaches, including dFMEA, human factors engineering, statistical software, and CAD.
• Create and maintain design history file documentation, including protocols, reports, design specifications, labeling, and drawings.
• Develop and execute test method validations, product testing, and verification and validation activities.
• Build prototypes, models, tooling, test fixtures, and assembly equipment, including operating machine tools when needed.

Requirements

• Bachelor’s degree in Mechanical, Plastics, Biomedical Engineering, or a related field; a master’s degree is preferred.
• 3–5+ years of experience developing Class II or Class III disposable medical products.
• Experience with stage-gate new product development processes.
• Working knowledge of plastics materials and processing, including injection molding, extrusion, ultrasonic welding, UV or solvent bonding, and sterilization.
• Working knowledge of CAD and PDM enterprise software, FDA Design Controls, ISO 13485, and ISO 14971 medical-device risk management.
• Ability to read, write, and comprehend English and work onsite at least 3 days per week in Plymouth, Minnesota.

Nice to have

• Design for Six Sigma training or certification.

Culture & Benefits

• Flexible workplace policy combining onsite collaboration with workplace flexibility.
• Medical, dental, and vision coverage starting on day one for eligible roles.
• Retirement savings through the Aon Pooled Employer Plan and hirify.global’s 401(k) plan.
• Paid holidays, 20–35 days of paid time off based on length of service, family and medical leave, and paid parental leave.
• Educational assistance, flexible spending accounts, commuting benefits, childcare benefits, and employee assistance programs.