Junior Product Development Engineer Job at ELIXIR MD Inc in Irvine

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

• Conduct  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 .

3. Testing & Validation

• 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.

4. Cross-Functional Collaboration

• 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.

5. Continuous Improvement

• 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.

6. Regulatory & Quality Support

• 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.

Typical Skills Required

• 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