Senior Supplier Development Engineer

Hamilton Medical

Supplier Development Engineer improving supplier quality, capability, and continuity for Hamilton Medical’s regulated ventilator manufacturing. Leading audits, qualifications, corrective actions, and cross-functional improvement projects.

Posted 8/17/2026full-timeReno • Nevada • 🇺🇸 United StatesSeniorWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in supplier quality management, including supplier qualification, audits, and performance monitoring, while ensuring compliance with FDA QMSR and ISO 13485 standards. Proficient in data analysis, process optimization, and cross-functional collaboration to drive supplier capability improvements in regulated manufacturing environments.

Highest-signal resume keywords

Supplier Quality ManagementFDA Quality Management System Regulation (QMSR)ISO 13485Supplier Audits and AssessmentsData Analysis

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Supplier QualificationProcess ValidationRoot Cause AnalysisStatistical Process Control (SPC)Engineering Drawings InterpretationChange Management SystemsPerformance Metrics EvaluationManufacturing Processes KnowledgeMaterial CertificationsTraceability Requirements

Soft Skills

Effective CommunicationCross-Functional CollaborationAdaptabilityProblem-Solving

Tools & Technologies

Microsoft Office SuiteECO/Change Management SystemsERP Systems (D365, SAP)Statistical Analysis Tools

Industry Keywords

Medical Device ManufacturingSupplier DevelopmentSupplier Risk ManagementBusiness Continuity PlanningRegulatory Compliance

Tech Stack

Tools & technologies

AssemblyERP

About the role

Key responsibilities & impact

Evaluate, select, qualify, and requalify suppliers based on technical capability, quality systems, manufacturing processes, capacity, and regulatory compliance
Conduct supplier audits and assessments and support supplier onboarding, qualification, design transfer, tooling transfers, and first article inspections
Drive supplier capability improvements through performance analysis, process optimization, capability studies, and structured improvement plans
Implement supplier quality requirements, inspection criteria, material certifications, and traceability requirements
Monitor supplier performance and risks related to process quality, delivery, capacity, and business continuity
Resolve supply disruptions, shortages, delivery issues, and supplier-related production process challenges
Manage supplier lifecycle risks, end-of-life components, replacement qualification, and supply continuity planning
Lead or support supplier nonconformance investigations and corrective action implementation and verification
Support Supplier Corrective Action Request activities and effectiveness verification
Evaluate supplier, engineering, and specification changes for qualification, change control, and regulatory compliance
Provide supplier qualification, audit, quality, technical, and performance documentation for regulatory and product lifecycle activities
Manage assigned projects and collaborate with Quality, Materials, Engineering, Production, and supplier organizations

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
Working knowledge of FDA Quality Management System Regulation (QMSR) (21 CFR Part 820) and/or ISO 13485 required
Proficient in ECO/change management systems, document control, data analysis, and Microsoft Office Suite
Able to read and interpret engineering drawings and GD&T required
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
Working knowledge of SPC, Cp/Cpk, sampling plans, trend analysis, and root cause analysis methodologies including 5 Whys, Fishbone, and 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
Working knowledge of QMSR, ISO 13485, supplier quality systems, process validation methodologies (IQ/OQ/PQ), material certifications, and traceability
Ability to work independently with minimal supervision, manage multiple priorities, adapt to changing business needs, and escalate significant risks or issues
Effective communication and cross-functional collaboration skills
Drug and background screenings required
Medical device, electronics, or other regulated manufacturing experience preferred
Supplier qualification or audit application preferred
Statistical analysis tools preferred
Familiarity with ERP or supplier management systems such as D365 or SAP preferred
Experience with supplier auditing, FAI, incoming inspection, process validation, or supplier quality improvement initiatives preferred

Benefits

Comp & perks

Medical, dental, and vision insurance
Paid vacation and sick time
Disability insurance
401(k)
Tuition reimbursement
Engaging and innovative design projects
Strong opportunities for professional growth
Commitment to sustainable design practices
Personal Protective Equipment (PPE) provided by employer when required