Supplier Development Engineer II
Listed on 2026-07-21
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Quality Assurance - QA/QC
Quality Engineering -
Engineering
Quality Engineering
Supplier Development Engineer II
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
- Supplier Performance & Risk Management
- Supplier Quality & Change Management
- Regulatory & Quality System Support
- Project & Cross-Functional Leadership
Qualifications:
- Technical & Supplier Development Competencies
- Regulatory & Quality Systems Knowledge
- Professional & Interpersonal Competencies
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.
- 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).
- Drug and background screenings required.
About Hamilton:
Mid Salary:
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