Senior Medical Device Supplier Development Engineer

Hamilton Medical; Reno (NV); On-site; USD 110,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

Paid vacation and sick time

Disability insurance

401(k)

Tuition reimbursement

Job summary

Hamilton Medical, Inc. in Reno, NV seeks a Senior Supplier Development Engineer to drive supplier qualification, development, and risk mitigation in a regulated medical device environment.

You will collaborate with Materials, Quality, and Engineering to ensure supply continuity and regulatory compliance. The role demands independent problem solving, strong communication, and a track record of improving supplier performance through audits, data analysis, and cross-functional leadership.

Qualifications

• 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), ISO 13485, supplier quality systems, process validation methodologies (IQ/OQ/PQ), and regulated manufacturing requirements including material certifications and traceability.
• 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.

Responsibilities

• 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.
• 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.
• 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 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.
• 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.

Skills

Manufacturing processes

Quality systems

GD&T

Process capability (Cp/Cpk)

Root cause analysis

Supplier audits

Education

Bachelor’s degree in Manufacturing/Mechanical/Industrial/Biomedical Engineering or related

Tools

Microsoft Office

ERP systems (D365, SAP)

Job description

Hamilton Medical, Inc. in Reno, NV seeks a Senior Supplier Development Engineer to drive supplier qualification, development, and risk mitigation in a regulated medical device environment.

You will collaborate with Materials, Quality, and Engineering to ensure supply continuity and regulatory compliance. The role demands independent problem solving, strong communication, and a track record of improving supplier performance through audits, data analysis, and cross-functional leadership.