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