What are the responsibilities and job description for the Component Engineer position at Katalyst CRO?
Responsibilities
- DVT & Design Release Support.
- 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.
- 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 risks.
- Assess manufacturability relative to supplier capabilities.
- Identify over-constrained tolerances and yield risks.
- Provide actionable DFM/DFA feedback.
- Cross-Functional Support
- 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.
- Bachelor degree in Electrical, Mechanical Engineering, or related technical field.
- 5 years of experience 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 experience working with cross-functional teams (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.
- Ability to read and critically review mechanical drawings.
- Working knowledge of GD&T (ASME Y14.5) principles.
- Understanding of tolerance stack-up and its impact on assembly and performance.
- Familiarity with common manufacturing processes (machining, molding, sheet metal) and associated constraints.
- Familiarity with design transfer processes and production ramp considerations.
- Familiarity with PLM systems (Propel) and ERP systems (NetSuite).
- Understanding of ISO 13485 and FDA 21 CFR Part 820 requirements preferred.
- Strong analytical and problem-solving skills with attention to detail.
- Ability to identify risks and provide clear, actionable recommendations.
- Effective communication across engineering and operations teams.
- Ability to work independently in high-impact role with minimal supervision.
- Strong organizational skills and ability to prioritize high value activities.
- Sitting at a desk utilizing a computer.
- Typical office areas with offices, cubicles and conference rooms.