Component Engineer – DVT / Design Release Support

Component Engineer – DVT / Design Release Support

ATR International, on behalf of our client, Diality, Inc.

About the Opportunity

ATR International is partnering with Diality, Inc. — a medical device company based in Irvine, CA developing the Moda-flx Hemodialysis System — to add a Component Engineer to their New Product Development team. This is a contract-to-hire role, on-site/local to Irvine, CA (candidates must already be local — no relocation support). This role is brought on to directly support DVT design release activities on a compressed schedule, offloading component-related work so core engineering can stay focused on design completion. Candidates from other highly regulated industries (e.g., aerospace, defense) with strong supply chain, quality, or component engineering fundamentals are also encouraged to apply.

Why This Role Matters

The team is compressing its design release timeline, and component readiness has been identified as a potential gating factor. This hire is intended to remove that risk by taking ownership of off-the-shelf component evaluation, lifecycle risk management, and alternate sourcing — allowing long lead-time, high-confidence parts to be ordered ahead of sub-system release.

What You'll Do

• Evaluate and release off-the-shelf (OTS) components to enable timely design completion and support ordering of long lead-time, high-confidence parts prior to sub-system release.
• Perform lifecycle risk assessments (NRND, EOL, long lead-time) to proactively mitigate supply and obsolescence risk.
• Identify alternate sources for single-sourced components.
• Partner with Engineering during product development to ensure component selections meet performance, cost, quality, and supply continuity objectives.
• Support design reviews by flagging component-related risks and recommending mitigation strategies prior to design release.
• Support Engineering Change Orders (ECOs) tied to component additions, substitutions, and obsolescence.
• Evaluate supplier changes, Product Change Notifications (PCNs), and EOL notices for business and technical impact.
• Ensure components comply with RoHS, REACH, and Conflict Minerals requirements.
• Maintain approved component specifications and sourcing data within PLM and ERP systems (Propel and NetSuite preferred).
• Serve as the primary technical point of contact between Engineering, Supply Chain, Quality, Manufacturing, and suppliers on component matters.
• Support manufacturing and supplier teams in resolving component issues during DVT and production builds.

What You Bring

• Bachelor's degree in a technical, business, or supply chain-related field (or equivalent hands-on experience).
• 5 years of experience as a Supply Chain Analyst, Quality Assurance Analyst, Quality Engineer, Supplier Quality Engineer, or Component Engineer — ideally in the medical device industry.
• Experience in another highly regulated industry (e.g., aerospace, defense) is welcomed if paired with strong supply chain or quality fundamentals.
• Hands-on experience managing component lifecycle status (Active, NRND, EOL), Product Change Notifications (PCNs), and obsolescence mitigation.
• Experience evaluating supply chain risk and developing alternate/second-source strategies for single-sourced components.
• Familiarity with RoHS, REACH, and Conflict Minerals compliance requirements.
• Experience reviewing component datasheets and supporting fit, form, and function evaluations for alternate components (design engineering background not required).
• Experience with PLM/ERP systems — Propel and NetSuite a plus.
• Experience in a regulated industry, with familiarity with ISO 13485 and FDA 21 CFR Part 820 / QMS requirements strongly preferred.
• Strong analytical, organizational, and cross-functional communication skills; self-motivated and comfortable managing multiple priorities in a fast-paced environment.

Logistics

• Location: Onsite — Irvine, CA (local candidates only; no relocation assistance)
• Engagement type: Contract-to-Hire
• Start: ASAP — targeted to support an active, compressed design release schedule
• Travel: None required

About Diality

Diality, Inc. is a medical device company based in Irvine, CA focused on developing solutions to improve the lives of people impacted by kidney disease. Diality's Moda-flx Hemodialysis System is a user-friendly, mobile, and connected hemodialysis platform designed to maximize clinical flexibility and ease of use for both clinical and non-clinical users, combining the flow rate capabilities of conventional in-center dialysis devices with a fully integrated reverse osmosis (RO) water filtration system.

About ATR International

ATR International is a nationwide staffing and workforce solutions firm specializing in engineering, technical, and professional placements across regulated industries including medical device, aerospace/defense, semiconductor, and biotech. We partner directly with hiring teams to move qualified candidates quickly through the process.