Supplier Engineer

Canon Recruiting Group • Maple Grove, MN

5d • $50 - $50 • Hybrid

About The Position

This project addresses a CAPA related to requirement to properly link design risks and design outputs to manufacturing processes performed by external suppliers. In this role, the Supplier Engineer will work closely with the design team to identify the key design outputs that are critical from a design-intent perspective, then collaborate with Sustaining Supplier Engineering (SE) and Quality Engineering (QE) to gather existing process validation documentation from suppliers. The team will review these validation packages against criteria developed from the design output list to determine whether each supplier meets minimum requirements. When gaps are identified, the engineer will partner with both the supplier and sustaining teams to remediate deficiencies, improve validation or documentation, and ensure alignment with expectations. This evaluation and remediation cycle will be repeated across all applicable contract manufacturers until all required supplier processes have been fully addressed. About the role: This Supplier Engineer (SE) will be responsible for the remediation activities identified by CAPA 7720 for contract manufactured (CM) sourced finished medical device (SFMD) product. This individual works independently, serves as a leader for SE remediation activities, and interacts cross-functionally with team members and CM SFMD suppliers to execute deliverables according to business needs.

Requirements

• Bachelor’s degree in engineering
• 1 – 2 years of experience in a manufacturing environment.
• Experience with installation qualifications (IQ), operational qualifications (OQ), performance qualification (PQ), and test method validation (TMV).
• Ability to travel up to 15% of the time (mostly domestic, could be international).

Nice To Haves

• Experience working with suppliers or in supply chain management.
• Experience working in the Medical Device Field.
• Excellent communication and project management skills.
• Strong bias for action and results oriented.
• Self-driven and self-motivated to learn and apply knowledge to produce results.
• Good understanding of statistical methods, six sigma methodologies, and problem-solving methodologies.

Responsibilities

• Review, remediate, and approve CM SFMD supplier’s process risk documentation (PFMEA) to newly defined criteria.
• Review, remediate, and approve CM SFMD supplier’s process and inspection validations to statistical requirements.
• Perform change management activities to remediate gaps found in CM SFMD Supplier’s process risk documentation and process/inspection validations.
• Collaborate with CM SFMD suppliers and functional resources to complete all activities needed to approve supplier’s process risk documentation and process/inspection validations to the newly defined criteria.
• In all actions, it demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level