Supplier Development Engineer

Katalyst CRO; Irvine (CA); On-site; USD 80,000 - 115,000; Full time

Job summary

Katalyst CRO in Irvine, CA, is looking for a candidate to bridge Engineering, Supply Chain, and Manufacturing, ensuring component choices are producible and aligned with supplier capabilities. The ideal candidate will identify and mitigate risks in component selection and tolerances to minimize production issues.

Applicants should hold a Bachelor's Degree in Engineering and have experience in the Medical Device Industry, along with strong mechanical and electro-mechanical aptitudes. Familiarity with PLM and ERP systems is also essential. Join us to enhance the reliability of our designs!

Qualifications

• Medical Device Industry experience is required.
• Familiarity with design transfer processes.
• Strong understanding of electronic, electromechanical, and mechanical components.

Responsibilities

• Participate in DVT readiness and design reviews.
• Support design transfer activities for manufacturing readiness.
• Evaluate lifecycle status and supplier risk.
• Provide actionable DFM/DFA feedback.
• Act as liaison between Engineering and Supply Chain.

Skills

Mechanical aptitude

Component Selection

Root Cause Analysis

Design Verification Testing

GD&T

Education

Bachelor's Degree in Engineering (BSME preferred)

Tools

PLM systems (Propel)

ERP systems (NetSuite)

Job description

Overview

This role operates as a technical bridge between Engineering, Supply Chain, and Manufacturing to ensure that component selections and mechanical designs are robust, producible, and aligned with supplier capabilities prior to production release.

The position is expected to identify and mitigate risks early, particularly in component selection, tolerancing, and manufacturability, to reduce downstream reliability issues, supply disruptions, and design rework.

Roles & Responsibilities

• Participate in DVT readiness and design reviews to identify component risks, manufacturability concerns, and documentation gaps.
• Support design transfer activities to ensure readiness for manufacturing release.
• Evaluate lifecycle status (NRND/EOL), supplier risk, and availability
• Recommend alternates and mitigation strategies.
• Support Release of OTS and custom parts
• Review drawings for dimensional accuracy, GD&T (ASME Y14.5), and tolerance stack-up risks.
• Assess manufacturability relative to supplier capabilities.
• Identify over-constrained tolerances and yield risks.
• Provide actionable DFM/DFA feedback.
• Act as liaison between Engineering and Supply Chain.
• Support supplier technical discussions.
• Assist in resolving build and early production issues.
• Support an effort of the supply chain activity by identifying long lead time items and engaging with the suppliers for potential cross-references.
• Support lifecycle advancement of components in Propel by ensuring complete specifications, compliance, and approved sourcing for pre-production readiness.
• Ensure alignment of component data across Propel/NetSuite.
• Support traceability and audit readiness.

Requirements

• Bachelor's Degree in Engineering (BSME preferred).
• Must have a mechanical/electro-mechanical aptitude.
• Medical Device Industry experience.
• DVT - Design Verification Testing.
• Experience evaluating component lifecycle (Active, NRND, EOL) and supply risk.
• Component Selection.
• GD&T.
• Root Cause Analysis.
• Design transfer processes.
• Familiarity with PLM systems (Propel) and ERP systems (NetSuite).
• Strong understanding of electronic, electromechanical, and mechanical components.