Principal Supplier Quality Engineer

Katalyst CRO; Arden Hills (MN); On-site; USD 90,000 - 120,000; Full time

Job summary

A medical technology company is seeking a Principal Supplier Engineer to bridge R&D and global supply chains. Responsibilities include working with suppliers to integrate designs, ensuring product compliance, and conducting audits. The ideal candidate will have a Bachelor's in engineering and over 7 years of experience in Medical Device development, with strong skills in design controls, risk management, and project management. This role requires global travel of 5-10%.

Qualifications

• 7+ years of technical experience in Medical Device development.
• Experience in design controls, risk management, and CAPA.
• Strong data analytics and critical thinking skills.

Responsibilities

• Identify supplier specifications to integrate designs into development.
• Generate and review quality plans and product specifications.
• Participate in supplier audits to assess compliance.

Skills

Design controls

Risk management

Process validation

Data analytics

Project Management

Cross-functional teamwork

Supplier controls compliance

Education

Bachelor's degree in engineering or related discipline

Job description

Job Description

• Must be able to travel 5‑10% globally (possible trips to Sweden, China, Finland, etc.) – approximately 5‑10 trips per year.
• As a Principal Supplier Engineer, will serve as the bridge between Boston Scientific Cardiac Diagnostics (CDx) cutting‑edge design and CDx’s global supply chain, integrating new and existing technologies.
• Work will directly impact the reliability, scalability, and speed at which life‑changing devices reach patients.
• As technical lead, work with R&D, Quality, Operations, and Regulatory teams to integrate OEM and sub‑system supplier designs and supplied components into CDx products, ensuring compliance, performance, and safety requirements are met.
• Role has a wide scope of responsibilities ranging from ensuring supplier design assurance, supplier product development integration assurance, and third‑party manufacturing assurance.

Responsibilities

• Working with Medical Device OEM, sub‑system and component suppliers to identify supplier specifications with the end goal of successfully integrating supplied designs and components into CDx’s development and manufacturing processes.
• Partnering with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Project Management to execute supplier control deliverables according to program needs, such as purchased material qualifications, supplier‑driven change assessments, supplier design or capability improvement projects, or regulated compliance assessments.
• Generating and reviewing quality plans, agreements, product specifications, component qualifications, design verification/validations, and process validations.
• Investigating complaints and managing supplier investigations for both design and manufacturing‑related issues.
• Participating in supplier audits to assess design and manufacturing compliance to regulatory standards and CDx agreed specification requirements. Audit activities include the evaluation of audit observations and findings, reporting, follow‑up, and confirmation of follow‑up actions.
• Acting as a technical expert to ensure repeatable and reproducible quality/reliability during the life of the product.

Requirements

• Bachelor’s degree in engineering or related discipline.
• 7+ years of technical experience working in Medical Device development processes.
• Experience in design controls, risk management, process validation, and CAPA.
• Design Assurance experience.
• Component and supplier qualification experience.
• Strong Project Management skills.
• ISO 13485 quality systems auditor (ISO 13485 Certified Auditor preferred).
• Self‑driven and results‑oriented with strong data analytics and critical thinking skills.
• Experience managing projects and working with cross‑functional teams to drive deliverables.
• Experience working with suppliers and familiar with the application of design controls and supplier controls as per 21CFR820 and MDR.
• Supplier design assurance, supplier product development integration assurance, and third‑party manufacturing assurance.