Supplier Development Engineer II

Hamilton Medical

Supplier Development Engineer II at Hamilton Medical developing and qualifying suppliers for regulated medical device manufacturing. Collaborating with cross-functional teams to enhance product quality and compliance.

Posted 7/17/2026full-timeReno • Nevada • 🇺🇸 United StatesMid-LevelSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supplier quality management, including supplier qualification, auditing, and regulatory compliance within the medical device manufacturing sector. Proficient in risk mitigation, process validation, and collaboration with cross-functional teams to enhance supplier performance and ensure product quality.

Highest-signal resume keywords

Supplier Quality ManagementFDA Quality Management System Regulation (QMSR)ISO 13485Supplier AuditingEngineering Drawings and GD&T

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier QualificationRisk MitigationProcess Validation (IQ/OQ/PQ)Data AnalysisStatistical Analysis ToolsECO/Change Management SystemsDocument ControlSupplier Quality Improvement InitiativesFirst Article Inspections (FAIs)Tooling Transfers

Tools & Technologies

Microsoft Office SuiteERP SystemsSupplier Management Systems (e.g., D365, SAP)

Industry Keywords

Medical Device ManufacturingRegulated ManufacturingSupplier DevelopmentManufacturing EngineeringQuality Assurance

Tech Stack

Tools & technologies

ERP

About the role

Key responsibilities & impact

Develop, qualify, and continuously improve supplier performance within a highly regulated medical device manufacturing environment
Partner with suppliers and cross-functional teams to ensure components and materials consistently meet technical, quality, delivery, and regulatory requirements
Drive supplier capability improvement, risk mitigation, supplier qualification, and supply continuity initiatives that support product quality and business objectives
Conduct supplier audits and assessments and support supplier onboarding, qualification, and design transfer activities, including supplier readiness, tooling transfers, and first article inspections (FAIs)
Monitor supplier performance, identify risks and trends related to process quality, delivery, capacity, and business continuity, and implement appropriate improvement and mitigation plans in collaboration with Quality Assurance and Materials teams
Evaluate supplier change notifications, engineering changes, and specification changes to ensure appropriate qualification, change control, and regulatory compliance

Requirements

What you’ll need

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

Benefits

Comp & perks

Comprehensive benefits package: medical, dental, vision insurance
Paid vacation and sick time
Disability insurance
401(k)
Tuition reimbursement