Junior Product Development Engineer (Irvine)ELIXIR MD Inc • Irvine, CA, United States
Junior Product Development Engineer (Irvine)
ELIXIR MD Inc • Irvine, CA, United States
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job_description.job_card.job_descriptionConduct literature, patent, and market research to inform product design decisions. Prepare and maintain design documentation, BOMs (Bill of Materials), and technical specifications . Assist in failure mode analysis and risk assessment (FMEA) to ensure regulatory compliance. Document test results, calibration reports, and validation protocols . Support prototype testing , including functional, mechanical, and electrical tests. Execute data collection and analysis to support design iteration and performance optimization. Assist in verifying compliance with internal standards, safety requirements, and regulatory guidelines (e.g., ISO 13485, IEC 60601). Prepare and maintain test logs and reports for engineering review and regulatory submissions. Collaborate with R&D, Clinical, and QA / RA teams to ensure product feasibility, safety, and regulatory compliance. Support manufacturing handoff , providing technical clarifications and documentation. Assist with supplier and contract manufacturer communications for component sourcing and prototype production. Participate in design reviews and team meetings , providing progress updates and recommendations. Identify opportunities for design optimization , cost reduction, and process improvement. Support troubleshooting and root cause analysis for product issues in prototypes or early production units. Maintain knowledge of emerging technologies, materials, and trends in the medical device and light therapy industry. Assist in maintaining design controls per FDA and ISO 13485 standards. Support documentation for regulatory submissions, design history files (DHF), and technical files . Participate in internal audits and corrective actions when necessary. CAD software (SolidWorks, Autodesk Inventor, etc.) Electrical & mechanical prototyping basics Basic firmware understanding (Arduino, C / C++) Understanding of product lifecycle & regulatory requirements Analytical skills and attention to detail
Junior Product Development Engineer
Location : Irvine, California ( In office only; No remote / hybrid)
Industry : Medical Devices (Global Aesthetic & Surgical Markets)
About Us
ELIXIR MD Inc. is a fast-growing fully integrated medical device innovator, headquartered in Irvine, CA. and proud Made in the USA ethos. Our manufacturing, supply, sales and support operations are global with sales in 22 countries (and growing). Our flagship device is transforming the way plastic surgeons practice worldwide. With rapid adoption, global expansion, and highly specialized logistics for a growing portfolio of Devices, we are looking for a Full time Junior Product Development Engineer to help scale our business with precision, creativity, and discipline.
Key Responsibilities
1. Product Design & Development
- Assist senior engineers in designing and developing new devices or product features , including hardware and software components.
- Create 3D CAD models, mechanical drawings, and schematics under guidance.
- Support prototyping efforts, including assembly, testing, and validation of early-stage products.
- Perform component selection (sensors, LEDs, microcontrollers, etc.) based on specifications and budget constraints.
- Assist in the integration of electronics, firmware, and mechanical subsystems for product development.
2. Research & Documentation
3. Testing & Validation
4. Cross-Functional Collaboration
5. Continuous Improvement
6. Regulatory & Quality Support
Typical Skills Required
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Product Development Engineer • Irvine, CA, United States
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