Component Engineer (Contract) — Remote (PST hours)
Pay Rate: $66.30/hr
About the Role
Our client, a privately held medical device company based in Irvine, CA, is developing a smart, portable hemodialysis machine that lets patients self-treat at home or on the go — without the need for pre-mixed dialysate bags or external water treatment. We're looking for a Component Engineer to support DVT and design release phases, with a focus on component risk reduction, compliance, manufacturability, and documentation quality.
This role acts as the technical bridge between Engineering, Supply Chain, and Manufacturing — ensuring component selections and mechanical designs are robust, producible, and aligned with supplier capabilities ahead of production release. You'll help catch risks early, particularly around component selection, tolerancing, and manufacturability, to reduce downstream reliability issues, supply disruptions, and design rework.
This is a remote position — candidates must be comfortable working West Coast (Pacific) business hours.
What You'll Do
DVT & Design Release Support
- Participate in DVT readiness and design reviews to flag component risks, manufacturability concerns, and documentation gaps
- Support design transfer activities to ensure manufacturing readiness
Component Risk & Lifecycle Assessment
- Evaluate lifecycle status (NRND/EOL), supplier risk, and availability
- Recommend alternates and mitigation strategies
- Support release of OTS and custom parts
Mechanical Drawing Review & Manufacturability
- Review drawings for dimensional accuracy, GD&T (ASME Y14.5), and tolerance stack-up risk
- Assess manufacturability against supplier capabilities
- Identify over-constrained tolerances and yield risks
- Provide actionable DFM/DFA feedback
Cross-Functional Support
- Serve as liaison between Engineering and Supply Chain
- Support supplier technical discussions
- Help resolve build and early production issues
- Identify long lead-time items and engage suppliers on cross-reference options
Data & Documentation
- Support lifecycle advancement of components in Propel, ensuring complete specs, compliance, and approved sourcing for pre-production readiness
- Ensure alignment of component data across Propel/NetSuite
- Support traceability and audit readiness
What You Bring
- Bachelor's degree in Electrical, Mechanical Engineering, or related technical field
- 5+ years in component engineering, hardware engineering, or a related technical role
- Experience supporting product development through DVT and design release phases
- Experience in a regulated environment (medical device preferred)
- Hands-on cross-functional experience (Engineering, Supply Chain, Manufacturing)
- Strong understanding of electronic, electromechanical, and mechanical components
- Experience evaluating component lifecycle (Active/NRND/EOL) and supply risk
- Ability to review datasheets and perform fit, form, and function analysis
- Strong mechanical drawing review skills and working knowledge of GD&T (ASME Y14.5)
- Understanding of tolerance stack-up and its impact on assembly/performance
- Familiarity with manufacturing processes (machining, molding, sheet metal)
- Familiarity with PLM (Propel) and ERP (NetSuite) systems
- Understanding of ISO 13485 and FDA 21 CFR Part 820 preferred
- Strong analytical skills, sound judgment, and ability to work independently
Company Description
ATR International is a staffing and workforce solutions firm providing high‐quality talent across a wide range of industries, including technology, operations, and professional services.