Process Engineer II (Medical Devices)

TL;DR

Process Engineer II (Medical Devices): Developing, optimizing, and scaling joining and welding processes for cardiovascular and neurological medical devices with an accent on laser and resistance welding applications. Focus on designing robust manufacturing processes, leading process improvement projects using DMAIC principles, and ensuring compliance with strict regulatory standards.

Location: Must be based onsite in Brooklyn Center, Minnesota, USA (5 days a week)

Salary: $84,000 - $126,000 USD

Company

hirify.global is a global leader in healthcare technology dedicated to alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Design, develop, and qualify robust joining and welding processes for new and existing medical products.
• Lead process improvement and cost-reduction initiatives using structured problem-solving and DMAIC principles.
• Manage critical process documentation including control plans, validation protocols, and engineering change orders.
• Collaborate with cross-functional teams to transfer processes from development to production.
• Optimize welding parameters through DOEs and statistical data analysis.
• Support nonconformance investigations and CAPA activities to drive root cause analysis.

Requirements

• Baccalaureate degree with 2+ years of relevant experience OR Master's degree with 0+ years of experience.
• Must possess unrestricted U.S. work authorization at the time of hire.
• Must be able to work onsite 5 days a week in Brooklyn Center, MN.
• Experience in manufacturing, process, or advanced manufacturing engineering.
• Hands-on experience with laser welding, resistance welding, or micro-joining.
• Ability to interpret engineering drawings and work in a regulated environment (ISO 13485/FDA).

Nice to have

• Experience with Lean, Six Sigma, or Green Belt certification.
• Knowledge of design for manufacturability (DFM) and statistical tools like Minitab.
• Prior work with automated joining cells and equipment qualification.

Culture & Benefits

• Comprehensive health, dental, and vision insurance.
• 401(k) plan with employer contribution and match.
• Paid time off and paid holidays.
• Tuition assistance and reimbursement programs.
• Employee Stock Purchase Plan and well-being programs.