Job Description

Principal Supplier Engineer

Schedule: Monday–Friday, Onsite

Employment Type: Long Term Contract to Hire

Location: Arden Hills, MN 55112

Salary: Up to $90 an hour or about $183,000 a year

Typical working hours: 8:00 AM – 4:30 PM

Work Authorization: Applicants must be authorized to work in the U.S. without current or future visa sponsorship. The client is unable to consider candidates requiring sponsorship.

Travel Requirements

• 5–10% travel (approximately 5–10 trips per year)
• Travel may include Europe, China, and domestic U.S. locations

Position Overview

As a Principal Supplier Engineer , you will serve as a critical bridge between Boston Scientific Cardiac Diagnostics (CDx) and its global supplier network. You will lead the integration of new and existing technologies into the supply chain, directly impacting the quality, reliability, and scalability of life-saving medical devices.

In this role, you will act as a technical leader collaborating cross-functionally with R&D, Quality, Operations, and Regulatory teams to ensure supplier designs and components meet all performance, safety, and compliance requirements .

Key Responsibilities

• Collaborate with OEM, sub-system, and component suppliers to define specifications and ensure successful integration into CDx development and manufacturing processes
• Lead cross-functional project teams and coordinate with Project Management, R&D, Design Assurance, Manufacturing Engineering, Operations, and Quality to execute supplier-related deliverables
• Develop and review quality plans, specifications, component qualifications, design verification/validation, and process validations
• Drive supplier design assurance and product development integration , ensuring compliance with regulatory and internal requirements
• Investigate complaints and manage supplier-related investigations for design and manufacturing issues
• Participate in and support supplier audits , including evaluation of findings, reporting, and corrective action follow-up
• Serve as a technical expert to ensure consistent product quality, reliability, and manufacturability across the product lifecycle
• Evaluate and qualify new and existing suppliers to support future product development and continuous improvement
• Perform risk assessments related to supplier capability, design, and supply continuity; implement mitigation strategies
• Lead supplier engineering activities across all project phases, including issue escalation and recovery planning with stakeholders and leadership
• Ensure compliance with Quality Policy and all applicable quality systems, processes, and procedures , with a strong focus on patient safety

Required Qualifications

• Bachelor’s degree in Engineering or related discipline
• Minimum 8+ years of experience in medical device development
• Strong experience with:
• Design Controls
• Risk Management
• Process Validation
• CAPA (Corrective and Preventive Actions)
• Ability to travel 5–10% internationally and domestically

Preferred Qualifications

• 10+ years of experience in medical device development, with design assurance exposure
• Experience working with suppliers and applying design and supplier controls per 21 CFR Part 820 and MDR
• Experience conducting quality system audits (ISO 13485 or similar)
• Strong analytical, critical thinking, and problem-solving skills
• Proven ability to manage cross-functional projects and drive deliverables
• Highly organized with the ability to manage multiple priorities simultaneously
• Excellent communication and interpersonal skills with the ability to build internal and external relationships

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