Supplier Development Engineer II

Company Overview

Hamilton Medical was founded in 1983 with a clear mission: to enhance the lives of patients on respirators and support the caregivers who serve them. Our focus is on developing ventilation technologies that prioritize safety, effectiveness, and lung protection. We are dedicated to easing the burden on healthcare professionals who work tirelessly every day, helping critically ill patients recover and regain their health.

We are committed to helping medical teams deliver the best respiratory care ‑ to anyone, anywhere.

Hamilton Medical, Inc. is seeking a Supplier Development Engineer II to develop, qualify, and continuously improve supplier performance within a highly regulated medical device manufacturing environment. This role partners with suppliers and cross‑functional teams to ensure components and materials consistently meet technical, quality, delivery, and regulatory requirements. The Supplier Development Engineer drives supplier capability improvement, risk mitigation, supplier qualification, and supply continuity initiatives that support product quality and business objectives.

The role requires close collaboration with Materials, Quality, and Production teams, and direct engagement with suppliers. A strong candidate is an independent problem solver, an effective communicator, and a positive driver of continuous improvement.

ESSENTIAL JOB FUNCTIONS:

Supplier Qualification & Development

• Evaluates, selects, qualifies, and requalifies suppliers based on technical capability, quality systems, manufacturing processes, capacity, and regulatory compliance.
• Conducts supplier audits and assessments and supports supplier onboarding, qualification, and design transfer activities, including supplier readiness, tooling transfers, and first article inspections (FAIs).
• Drives supplier capability improvements through performance analysis, process optimization, capability studies, and structured improvement plans.
• Implements supplier quality requirements, including inspection criteria, material certifications, and traceability requirements, in collaboration with Quality Assurance and Engineering.

Supplier Performance & Risk Management

• Monitors supplier performance, identifies risks and trends related to process quality, delivery, capacity, and business continuity, and implements appropriate improvement and mitigation plans in collaboration with Quality Assurance and Materials teams.
• Collaborates with suppliers and internal stakeholders to resolve supply disruptions, shortages, delivery issues, and other supplier‑related challenges due to production process issues.
• Manages supplier‑related lifecycle risks, including end‑of‑life (EOL) components, replacement qualification, and supply continuity planning.

Supplier Quality & Change Management

• Leads or supports investigations of supplier nonconformances and performance issues using structured problem‑solving methodologies and supports implementation and verification of corrective actions.
• Supports Quality Assurance in Supplier Corrective Action Request (SCAR) activities, including supplier investigations, corrective action follow‑up, and effectiveness verification.
• Evaluates supplier change notifications, engineering changes, and specification changes to ensure appropriate qualification, change control, and regulatory compliance.

Regulatory & Quality System Support

• Provides supplier qualification, audit, and quality documentation and supports internal, customer, and regulatory audits and submissions as required.
• Provides supplier qualification records, technical documentation, and supplier performance data to support regulatory compliance and product lifecycle activities.

Project & Cross‑Functional Leadership

• Manages assigned projects and collaborates across Quality, Materials, Engineering, Production, and supplier organizations to achieve project and business objectives.
• Performs other duties as assigned.

Technical & Supplier Development Competencies

• Strong understanding of manufacturing processes, materials, machining, molding, assembly, process controls, and supplier manufacturing technologies used in medical device…