ISO 13485 FDA

regulations

Full Job Description 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.

Responsibilities:

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.

Qualifications:

Technical & Supplier Development Competencies Strong understanding of manufacturing processes, materials, machining, molding, assembly, process controls, and supplier manufacturing technologies used in medical device manufacturing. Ability to evaluate supplier technical capabilities, manufacturing processes, equipment, and process capability against engineering, quality, and business requirements. Proficient in interpreting engineering drawings, GD&T, component specifications, and technical documentation. Working knowledge of statistical and quality tools including SPC, process capability analysis (Cp/Cpk), sampling plans, trend analysis, and root cause analysis methodologies (5 Whys, Fishbone, 8D). Ability to conduct supplier audits and assessments and evaluate supplier performance using quality, delivery, capacity, and risk-based metrics. Working knowledge of supplier qualification, supplier development, supplier risk management, ASL management, business continuity planning, and supplier performance monitoring. Regulatory & Quality Systems Knowledge Working knowledge of FDA Quality Management System Regulation (QMSR), ISO 13485, supplier quality systems, process validation methodologies (IQ/OQ/PQ), and regulated manufacturing requirements including material certifications and traceability. Professional & Interpersonal Competencies Independent problem solver who applies engineering principles, sound judgment, and structured decision-making to supplier quality, development, and operational challenges. Able to work independently with minimal supervision, manage multiple priorities, adapt to changing business needs, and appropriately escalate significant risks or issues. Effective communicator and cross-functional collaborator with the ability to communicate technical and quality requirements to suppliers and internal stakeholders.

Education/Experience:

3-7 years of experience in supplier quality, supplier development, manufacturing engineering, or a closely related field. Bachelor's degree in Manufacturing, Mechanical, Industrial, Biomedical Engineering, or a closely related discipline required. Direct experience working with external suppliers on quality and technical matters; medical device, electronics, or other regulated manufacturing experience preferred. Working knowledge of FDA Quality Management System Regulation (QMSR) (21 CFR Part 820) and/or

ISO 13485

required; supplier qualification or audit application preferred. Proficient in ECO/change management systems, document control, data analysis, and Microsoft Office Suite; statistical analysis tools preferred. Able to read and interpret engineering drawings and GD&T required. Familiarity with ERP or supplier management systems (e.g., D365, SAP) preferred. Experience with supplier auditing, FAI, incoming inspection, process validation (IQ/OQ/PQ), or supplier quality improvement initiatives preferred.

About Hamilton:

Established, stable, and reliable company.

Comprehensive benefits package:

medical, dental, vision insurance; paid vacation and sick time; disability insurance; 401(k); tuition reimbursement; and more. Engaging and innovative design projects. Strong opportunities for professional growth. Commitment to sustainable design practices. Personal Protective Equipment (PPE) may be required (provided by employer). 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