NPI Engineer
InternMidR&DMedical DevicesUnknown
Description
Seeking a highly skilled and motivated R&D LCM (Life Cycle Management) Engineer to lead technical engineering support within R&D. The role owns technical aspects of legacy products and New Product Introductions (NPI), ensuring seamless design transfer and robust support across the product lifecycle. Acts as the primary technical interface between R&D, production, and quality.
Key Responsibilities:
- Lead the NPI process from engineering handoff to production ramp-up.
- Collaborate with contract manufacturers, suppliers, and internal teams to ensure a smooth transition from design to volume production.
- Provide technical support for legacy products.
- Manage component obsolescence, implement design improvements, and resolve production issues.
- Assist in prototype development, assembly, and iterative testing.
- Conduct hardware and software verification to ensure design compliance.
- Evaluate and approve component replacements, alternative parts, and ECOs.
- Perform component-level troubleshooting of electrical and electronic systems.
- Lead RCA and implement CAPA for field and production issues.
- Support product certification processes (e.g., EMC, Safety) and other regulatory requirements.
- Ensure compliance with applicable standards and maintain documentation quality.
- Serve as the technical point of contact for manufacturing and QA teams.
- Provide real-time engineering support on the production floor. Ensure alignment between R&D design intent and production execution.
Requirements
Electrical Practical Engineer (or equivalent) with strong hands-on technical skills. Proficient in reading electrical schematics and performing component-level troubleshooting. Minimum 5 years of experience in engineering support roles; medical device industry experience is a strong advantage. Proven experience with multi-disciplinary systems (mechanical, electrical, software). Strong analytical and problem-solving abilities; self-driven with a 'can-do' approach. Familiarity with production environments and quality assurance processes. Experience working with contract manufacturers and external suppliers. Excellent verbal and written communication skills in Hebrew and English. Ability to manage multiple tasks in a fast-paced, cross-functional environment. Desirable Skills (Advantages): Experience with design transfer documentation and validation protocols. Knowledge of ISO 13485, FDA QSR, or other medical regulatory standards. Familiarity with PLM systems, CAD tools, or lab test equipment.
Lumenis
BIOTECHNOLOGY
Energy-based medical treatments
LocationAustralia - Chatswood
Employees1001-5000
Open Jobs18
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