Quality Engineer I (Medtech)

TL;DR

Quality Engineer I (Medtech): Developing and maintaining quality standards, inspection methods, validation protocols, and compliance documentation for peripheral vascular medical devices with an accent on manufacturing quality, process reliability, and regulatory compliance. Focus on analyzing quality risks, validating processes and test methods, improving yields, and implementing sustainable solutions across cross-functional engineering and manufacturing teams.

Location: Onsite at the Plymouth Nathan Lane facility in Plymouth, Minnesota, United States, at least 5 days per week. Very limited travel is required. Candidates must have unrestricted U.S. work authorization at the time of hire and throughout employment; sponsorship is not available for roles below Principal level.

Salary: $66,400–$99,600 annually, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global is a global medical technology company developing healthcare products and solutions intended to alleviate pain, restore health, and extend life.

What you will do

• Develop, modify, apply, and maintain quality standards and protocols for materials, products, and production processes.
• Partner with Manufacturing, Engineering, Operations, Regulatory, and other functions to identify risks and implement quality improvements.
• Design and specify inspection and testing methods and equipment for products and production equipment.
• Conduct quality assurance testing and statistical analysis to evaluate product and process performance.
• Support manufacturing operations, capacity expansion, equipment replacement, yield improvement, technology changes, and Lean transformation initiatives.
• Ensure corrective actions meet reliability standards and that quality documentation complies with applicable requirements.

Requirements

• Baccalaureate degree with 0 years of relevant experience.
• Unrestricted U.S. work authorization is required; H-1B, TN, J, and other sponsorship is not available for this role.
• Ability to work onsite at least 5 days per week at the Plymouth Nathan Lane facility.
• Strong problem-solving, technical judgment, critical-thinking, analytical, written, and verbal communication skills.
• For degrees earned outside the United States, the degree must satisfy the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A).

Nice to have

• Experience reviewing technical documentation.
• Process validation experience, including installation qualification, process characterization, operational qualification, and performance qualification.
• Experience developing, executing, and analyzing test method validations.
• Experience with Master Validation Records and risk management documentation, including DFMEA and PFMEA.
• General understanding of project management.

Culture & Benefits

• Mission-driven work focused on improving patient health through medical technology.
• Cross-functional, collaborative environment supporting the Peripheral Vascular Health operating unit.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
• 401(k) plan with employer contribution and match, paid time off, paid holidays, incentive plans, and employee stock purchase plan.
• Tuition assistance or reimbursement and a global well-being program.