Principal Supplier Quality Engineer (Medtech)

TL;DR

Principal Supplier Quality Engineer (Medtech): Driving supplier quality excellence to support the development and launch of innovative cardiac surgery devices with an accent on component development, qualification, and regulatory compliance. Focus on managing strategic contract manufacturers, leading supplier qualification strategies, and resolving change-related issues during the NPD lifecycle.

Location: Onsite in Brooklyn Park, Minnesota, USA (minimum 4 days per week in office)

Salary: $120,000 - $180,000

Company

hirify.global is a global healthcare technology leader dedicated to alleviating pain, restoring health, and extending life through engineering innovation.

What you will do

• Provide Pre-Market Supplier Quality Engineering support for New Product Development (NPD) to ensure the delivery of high-quality parts and materials.
• Implement strategies for product quality and continuous improvement, ensuring compliance with industry and regulatory standards.
• Manage strategic Contract Manufacturers (CMs), overseeing product/process changes and performance oversight.
• Lead supplier qualification strategies and manage quality deliverables for major or moderately complex projects.
• Plan and lead supplier audits to assess compliance with regulatory standards and internal procedures.
• Collaborate with cross-functional teams (Sourcing, R&D, Operations) to resolve supplier issues and align expectations.

Requirements

• Must be based in or have unrestricted authorization to work in the USA.
• Baccalaureate degree with 7+ years of relevant experience, Master's with 5+ years, or PhD with 3+ years.
• Strong working knowledge of global medical device regulations and requirements.
• Experience with manufacturing assembly processes and inspection/testing methods.
• Ability to work onsite in Brooklyn Park, MN (minimum 4 days per week).

Nice to have

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

Culture & Benefits

• Competitive salary and hirify.global Incentive Plan (MIP).
• Comprehensive health, dental, and vision insurance with HSA and FSA options.
• 401(k) plan with employer contribution and match.
• Employee Stock Purchase Plan and non-qualified retirement plan supplements.
• Paid time off, paid holidays, and tuition reimbursement.
• Global well-being program (Simple Steps).