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AllSTEM Connections

Principal Mechanical Engineer

AllSTEM Connections, Irvine, California, United States, 92713

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Overview Recruiting Manager at AllSTEM Connections, an ActOne Group

Job Title: Principal Mechanical Engineer Reports To: Director of Engineering, Chief Engineer Location: Irvine, CA (On-Site)

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 role supports an expanding operation for commercialization of next-generation prosthetic feet, ankles, knees, and legs. The candidate will work closely with the engineering and operations teams to provide ongoing engineering support of prosthetic limbs. The ideal candidate will have strong technical knowledge, leadership in developing complex mechanical solutions for medical devices, and a proven hands-on track record contributing from concept to launch.

Responsibilities

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.

Provide 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.

Perform additional tasks and responsibilities as needed.

Qualifications

Strong technical knowledge in mechanical design for medical devices.

Hands-on engineering experience from concept to launch.

Leadership experience in mentoring engineers and guiding projects.

Experience with risk analysis, verification/validation, and regulatory considerations for medical products.

Seniority level

Mid-Senior level

Employment type

Full-time

Job function

Engineering

Industries

Manufacturing

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