Principal Supplier Quality Engineer (Medtech)

TL;DR

Principal Supplier Quality Engineer (Medtech): Driving supplier quality excellence for new product development within the CardioVascular Surgery Operating Unit with an accent on component qualification, regulatory compliance, and cross-functional collaboration. Focus on managing strategic contract manufacturers, leading supplier audits, and ensuring robust quality processes for innovative aortic devices.

Location: Must be based in Brooklyn Park, Minnesota, USA. The role is hybrid (onsite minimum 4 days per week).

Salary: $123,200 – $184,800 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

• Provide Pre-Market Supplier Quality Engineering support for New Product Development (NPD) to ensure high-quality parts and materials.
• Manage strategic contract manufacturers, overseeing performance, process changes, and continuous improvement initiatives.
• Lead supplier qualification strategies and manage quality deliverables for complex projects.
• Plan and conduct supplier audits to ensure compliance with regulatory standards and internal procedures.
• Collaborate with cross-functional teams including Sourcing, R&D, and Operations to resolve supplier-related issues.
• Mentor and delegate work to lower-level specialists on supplier quality deliverables.

Requirements

• Baccalaureate degree with 7+ years of relevant experience, or Master's with 5+ years, or PhD with 3+ years.
• Experience with global medical device regulations and requirements.
• Demonstrated project management capabilities and ability to coordinate complex timelines.
• Experience with manufacturing assembly processes and inspection/testing methods.
• Ability to work onsite in Brooklyn Park, MN at least 4 days per week.
• Must possess unrestricted U.S. work authorization (sponsorship available for Principal level).

Nice to have

• Engineering experience with disposable medical devices or capital equipment.
• Experience executing the Production Part Approval Process (PPAP).
• Lead Auditor certification (ISO 13485 or ISO 9001).
• Understanding of heart anatomy and human physiology.

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 short-term incentive plans.
• Commitment to professional growth and cross-functional collaboration.