Sustaining Engineer II (Medical Devices)

TL;DR

Sustaining Engineer II (Medical Devices): Supporting and improving high-volume production of perfusion systems with an accent on process stability, yield, quality, and manufacturing efficiency. Focus on validating processes, applying DMAIC and statistical methods, reducing scrap and cycle time, and maintaining reliable production lines in a regulated medical-device environment.

Location: Brooklyn Park, Minnesota, United States; 5 days per week onsite. Candidates below the Principal level must have unrestricted U.S. work authorization; visa sponsorship is not available for this role.

Salary: $81,600–$122,400 USD per year, plus eligibility for the hirify.global Incentive Plan.

Company

hirify.global develops healthcare technologies and medical devices designed to alleviate pain, restore health, and extend life.

What you will do

• Provide daily engineering support for high-volume perfusion-system production and own assigned production-line performance.
• Lead improvement projects focused on process efficiency, yield, product performance, uptime, and business continuity.
• Reduce scrap and cycle time using Lean Manufacturing, standard work, visual management, and waste elimination.
• Plan and execute process validations, test method validations, statistical studies, and production problem-solving activities.
• Specify or support commissioning of capital equipment and transfer new or improved designs into production.
• Collaborate with Operations, Quality, Process Development, Reliability Engineering, and Regulatory Affairs to resolve production, customer-return, and process-variability issues.

Requirements

• Bachelor's degree with at least 2 years of relevant experience, or a master's degree with no minimum experience requirement.
• Unrestricted U.S. work authorization is required at hire and throughout employment; sponsorship is unavailable below the Principal level.
• Experience applying engineering, statistical, and process-improvement methods in a manufacturing environment.
• Ability to create technical documentation, including test plans, reports, qualifications, risk assessments, and work instructions.
• Ability to work independently and cross-functionally in a fast-paced production environment.

Nice to have

• Medical-device manufacturing experience, especially high-volume production or Class II/III devices.
• Green Belt certification or Lean Six Sigma and DMAIC training.
• Experience with Minitab, JMP, PowerBI, capital equipment, Kaizen, or Value Stream Mapping.
• Experience with materials, manufacturing processes, and cost-, cycle-time-, or scrap-reduction initiatives.

Culture & Benefits

• Five-day onsite collaboration at the Brooklyn Park manufacturing site.
• Health, dental, vision, life, disability, and flexible spending benefits for eligible regular employees.
• 401(k) contributions and match, paid time off, paid holidays, and employee stock purchase plan.
• Tuition assistance, employee assistance resources, and a global well-being program.
• Short-term incentive eligibility through the hirify.global Incentive Plan.