Senior Quality Engineer (Medical Devices)

Location: Onsite at the Nathan Lane facility in Plymouth, Minnesota, United States, with limited travel. Candidates below the Principal level must have unrestricted U.S. work authorization at the time of hire and throughout employment.

Salary: $98,400–$147,600 per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies, including peripheral vascular products and services, to improve patient outcomes worldwide.

What you will do

• Represent Quality Engineering on sustaining, manufacturing, and operational improvement projects.
• Support capacity expansion, equipment replacement, technology implementation, yield improvement, and lean transformation initiatives.
• Analyze manufacturing and quality data to identify root causes and implement corrective actions.
• Develop and execute risk assessments, qualifications, validations, and technical documentation.
• Review and approve process changes, product dispositions, CAPA, and quality system documentation.
• Provide technical guidance and mentorship on quality engineering principles and applications.

Requirements

• Bachelor’s degree in Mechanical, Biomedical, Manufacturing, or related Engineering and at least 4 years of relevant experience, or an advanced degree with at least 2 years of relevant experience.
• Experience supporting quality engineering activities in a regulated manufacturing environment.
• Experience analyzing technical or process data for investigations, root cause analysis, and corrective actions.
• Experience creating, reviewing, or approving technical documentation for manufacturing or quality systems.
• Unrestricted U.S. work authorization is required; sponsorship is not available for this Senior-level role.

Nice to have

• Experience with IQ, OQ, and PQ process validation activities.
• Experience with Test Method Validations and validation documentation.
• Knowledge of DFMEA, PFMEA, Master Validation Records, DOE, SPC, capability studies, and hypothesis testing.

Culture & Benefits

• Purpose-driven work developing technologies intended to alleviate pain, restore health, and extend life.
• Health, dental, and vision insurance, plus HSA and healthcare FSA options for eligible regular employees.
• Life insurance, disability coverage, paid time off, paid holidays, and employee assistance programs.
• 401(k) plan with employer contribution and match, employee stock purchase plan, and incentive plans.
• Tuition assistance or reimbursement and a global well-being program.