Job Type

Full-time
Description
Job Title:
Principal Mechanical Engineer
Reports To:
Director of Engineering, Chief Engineer
Location:
Irvine, CA (On-Site)
Job Overview
The Principal Mechanical Engineer is responsible for the full lifecycle of mechanical design development for the company's prosthetic products, including research, mechanical system design, analysis, requirements, risk analysis, design documentation, development, validation, and verification of all related components.
This will support an expanding operation for commercialization of our next-generation prosthetic feet, ankles, knees, and legs. Working closely with the engineering and operations teams, they will be responsible for the ongoing engineering support of prosthetic limbs.
The ideal candidate will possess strong technical knowledge, experience, and leadership in developing complex mechanical solutions for medical devices. They will have a proven track record as a hands-on engineer and possess the ability to contribute to the development of products from concept to launch.
Requirements
Key Responsibilities and Duties

• Lead design, development, and release of detailed prosthetic components, subsystems, and complex mechanical systems
• Plan, design, validate, and implement product changes.
• Lead development and execution of verification and validation plans and protocols, regulatory certifications.
• Provide engineering support to internal and external customers, including manufacturing, sales, clinical services, medical practitioners, and product users.
• Collaborate with Engineering team members to determine feasibility, scope, and feature sets for mechanical-related technologies.
• Responsible for technical leadership and/or mentorship of multiple engineers.
• Develop and manage budgets for projects.
• Serve as subject matter expert for mechanical-related technologies.
• Identify, develop, and prepare submissions for intellectual property.
• Tasks and responsibilities assigned as needed.

Required Skills/Abilities

• Strong ethics, leadership, ambition, drive, and results-oriented.
• Planning, prioritization, organizational, and communication skills.
• Knowledge of product development life cycle, including planning, hazard analysis, requirements analysis, detailed design, development, verification, and validation testing in a process-driven environment.
• Working knowledge of design control procedures, design transfer to manufacturing, regulatory requirements, FDA, IEC, CE, ISO, IEEE.
• Structured problem-solving skills (e.g., Six Sigma, DMIAC) and failure analysis experience desired.
• Prosthetic design experience desired.
• Expert knowledge of mechanical design, analysis, and FEA.
• High proficiency using computer aided design (CAD) packages such as SolidWorks.
• Strong electro-mechanical design experience.
• Expert hydraulic, pneumatic, or actuator design experience.

Education and Experience

• Master's or Ph.D. degree in Mechanical Engineering or equivalent engineering discipline.
• 10 years of relevant experience.

Physical Requirements

• Prolonged periods of sitting at a desk and working on a computer.
• Must be able to lift up to 15 pounds at a time.
• Travel 5% or less.

Salary Description

$150,000-$170,000 DOE