Senior Mechanical Engineer

3DT Holdings; San Diego (CA); On-site; USD 100,000 - 150,000; Full time

Job summary

3DT Holdings in San Diego, CA is seeking a Senior Mechanical Engineer to design, verify, and optimize mechanical components for medical devices across the product lifecycle. You will create CAD models in SolidWorks, perform analyses, lead prototype builds, and maintain risk management files per ISO 14971, while coordinating with Quality, Regulatory, Manufacturing and Program Management.

The role requires a strong background in medical device development, DFx, and experience with FDA/ISO design

Qualifications

• Bachelor's degree in mechanical engineering or a related field.
• 5+ years of medical device product development experience.
• Proficiency with SolidWorks and design of complex assemblies.
• Experience with design verification, statistical methods, and test method development.
• Experience with risk management, technical documentation, and product testing.

Responsibilities

• Apply mechanical engineering principles to the development, evaluation, and improvement of medical device components and assemblies.
• Proficiency in medical device design, including mechanisms, material selection, and tolerance analysis for complex assemblies.
• Hands-on experience with SolidWorks for 3D modeling and detailed drawings.
• Background in Research and Development (R&D), including prototyping, testing, data analysis, and iterative design improvement.
• Experience with design for manufacturability (DFM), design for assembly (DFA) for molded polymer materials.
• Develop and maintain risk management files (FMEA, hazard analysis) per ISO 14971.
• Project Management skills to organize tasks, track milestones, and collaborate effectively with cross-functional teams.
• Background with medical device standards, quality systems, and regulatory requirements (e.g., ISO 13485, FDA).
• Strong analytical, problem-solving, and communication skills, with the ability to document work clearly and work independently and in teams.

Skills

SolidWorks proficiency

Cross-functional collaboration

Risk management

Design verification

Statistical methods

Education

Bachelor's degree in mechanical engineering

Tools

SolidWorks

MS Office

Statistical analysis tools

Job description

Job Title: Senior Mechanical Engineer Job Type: Full Time (40 hours a week)

Department: Engineering Salary Rate: $100,000 - $150,000 annual

Duration: Permanent

Position Summary

The Senior Mechanical Engineer supports the design, development, verification, validation, and optimization of mechanical components and assemblies for medical devices throughout the product lifecycle. Responsibilities include creating and maintaining detailed CAD models and engineering drawings, performing engineering analyses, leading prototype builds, planning and executing characterization and verification testing for new and existing products.

The role involves collaborating with cross-functional teams including Quality, Regulatory, Manufacturing, Clinical, and Program Management.

Key Responsibilities

• Apply mechanical engineering principles to the development, evaluation, and improvement of medical device components and assemblies.
• Proficiency in medical device design, including mechanisms, material selection, and tolerance analysis for complex assemblies.
• Hands-on experience with SolidWorks for 3D modeling and detailed drawings.
• Background in Research and Development (R&D), including prototyping, testing, data analysis, and iterative design improvement.
• Experience with design for manufacturability (DFM), design for assembly (DFA) for molded polymer materials.
• Develop and maintain risk management files (FMEA, hazard analysis) per ISO 14971.
• Project Management skills to organize tasks, track milestones, and collaborate effectively with cross-functional teams.
• Background with medical device standards, quality systems, and regulatory requirements (e.g., ISO 13485, FDA).
• Strong analytical, problem-solving, and communication skills, with the ability to document work clearly and work independently and in teams.

Minimum Qualifications

• Bachelor's degree in mechanical engineering or a related technical field.
• 5+ years of medical device product development experience.
• Proficiency with SolidWorks and mechanical design of complex assemblies.
• Experience with design verification, statistical methods, and test method development.
• Experience with risk management, technical documentation, and product testing.

Preferred Qualifications

• Experience with Class II or Class III medical devices.
• Strong knowledge of FDA 21 CFR Part 820/QMSR, ISO 13485, ISO 14971, and design controls.
• Experience supporting FDA 510(k), De Novo, or international regulatory submissions.
• Strong technical writing skills; SolidWorks, MS Office, and statistical/analysis tools.
• Detail-oriented with strong organizational, communication, and time management skills.
• Collaborative and solutions-oriented; able to work cross-functionally and influence without authority.