Senior Supplier Engineer

Advantage Technical; Minneapolis (MN); On-site; USD 85,000 - 110,000; Full time

Job summary

A leading supplier company is seeking a Senior Supplier Engineer to join their Cardiac Diagnostics division. This role involves collaborating with various teams to ensure the flawless integration of components into products, driving compliance and quality assurance. Candidates should have at least 5 years of experience in medical device development and strong analytical skills. The position requires a hybrid model of working, with a commitment to quality and regulatory standards upheld throughout the engineering process.

Qualifications

• 5+ years of technical experience in medical device development.
• Strong design assurance background.
• Ability to travel 5–10% globally.

Responsibilities

• Collaborate with suppliers to define specifications and ensure seamless integration.
• Lead supplier design assurance activities and compliance.
• Evaluate supplier process capabilities and drive improvement actions.

Skills

Design controls

Risk management

Process validation

CAPA

Strong analytical skills

Excellent communication skills

Education

Bachelor’s degree in engineering or a related discipline

Tools

ISO 13485

Job description

Work Authorization: Must be authorized to work in the U.S. now and in the future (no sponsorship available)

About the Role

As a Senior Supplier Engineer with Boston Scientific’s Cardiac Diagnostics (CDx) division, you’ll play a pivotal role in connecting innovative product design with a global, high‑performance supply chain. Your work will directly influence the reliability, scalability, and timely delivery of life‑changing cardiac diagnostic technologies to patients around the world.

In this highly technical and collaborative role, you’ll partner with R&D, Quality, Operations, and Regulatory teams to integrate OEM, subsystem, and component supplier designs into CDx products. You’ll ensure that every supplied component meets stringent performance, safety, and compliance requirements—while driving continuous improvement across supplier capabilities and manufacturing processes.

This position follows a hybrid onsite model, requiring at least three days per week onsite to support hands‑on engineering discussions, supplier integration activities, and cross‑functional problem‑solving.

Key Responsibilities

• Collaborate with OEM, subsystem, and component suppliers to define specifications and ensure seamless integration into CDx development and manufacturing processes.
• Lead supplier design assurance activities, ensuring compliance with performance, safety, and regulatory requirements.
• Evaluate supplier process capabilities and drive corrective and preventive actions to enhance quality, reliability, and manufacturability.

Cross‑Functional Collaboration

• Partner with R&D, Design Assurance, Manufacturing Engineering, Operations Quality, and Program Management to execute supplier control deliverables.
• Support purchased material qualifications, supplier‑driven change assessments, capability improvement initiatives, and compliance evaluations.

Quality & Compliance Leadership

• Develop and review quality plans, supplier agreements, product specifications, component qualifications, and validation documentation.
• Investigate supplier‑related design and manufacturing issues, ensuring timely resolution and documentation.
• Participate in supplier audits, assess compliance with regulatory standards and CDx requirements, and ensure follow‑up actions are completed.

Technical Expertise & Continuous Improvement

• Serve as a technical expert ensuring consistent product quality and reliability throughout the product lifecycle.
• Assess new and emerging supplier technologies for future product integration or quality improvement.
• Conduct risk assessments related to supplier capability, design, and supply processes to support continuity of supply.
• Coordinate all phases of supplier engineering activities, communicating risks, emerging issues, and recovery plans to leadership and stakeholders.
• Demonstrate a strong commitment to patient safety and product quality by adhering to all quality policies, procedures, and regulatory requirements.

Required Qualifications

• Bachelor’s degree in engineering or a related discipline
• Minimum 5 years of technical experience in medical device development
• Experience with design controls, risk management, process validation, and CAPA
• Ability to travel 5–10% globally (including Sweden, China, Finland, and domestic travel)

Preferred Qualifications

• 7+ years of medical device development experience with strong design assurance background
• Experience applying supplier controls per 21 CFR 820 and MDR
• Auditor experience with ISO 13485 or similar quality systems
• Strong analytical and critical‑thinking skills with a data‑driven approach
• Proven ability to lead cross‑functional projects and drive deliverables
• Highly organized with the ability to manage multiple priorities
• Excellent interpersonal and communication skills for building strong internal and external partnerships