Senior Mechanical Engineer, Medical Devices SolidWorks/GD&T

Advanced Sterilization Products, Inc.; Irvine (CA); On-site; USD 101,000 - 169,000; Full time

Benefits offered by this job

Bonus potential

Job summary

Advanced Sterilization Products, Inc. seeks an experienced Senior Mechanical Engineer to plan and execute mechanical design and development for complex medical device components and subsystems.

You will independently create 3D models, detailed drawings, and specifications with GD&T, and develop test protocols to validate performance while ensuring regulatory compliance. The role requires a strong background in regulated environments, solid proficiency in SolidWorks and design-for-manufacturing,

Qualifications

• Bachelor’s degree in Mechanical Engineering or related field.
• 10+ years of mechanical design experience in regulated industry (or 7+ years with Master’s).
• Proficient in SolidWorks and GD&T principles.
• Strong knowledge of design for manufacturing and testability.
• Demonstrated problem-solving and analytical skills.
• Effective verbal and written communication.
• Familiarity with electrical safety standards.
• Proficiency in Microsoft Office, Visio, and collaboration tools.
• Ability to coordinate projects and influence cross-functional teams.
• Uses general hand and laboratory tools.
• Domestic and International travel as required.

Responsibilities

• Plan and conduct mechanical design and development for complex components and subsystems.
• Independently create and validate 3D models, drawings, and specs with GD&T compliance.
• Develop and execute test protocols; analyze results and propose design improvements.
• Conduct design reviews and provide technical expertise to resolve issues.
• Execute and document verification and validation testing.
• Prepare technical documentation, proposals, and cost estimates.
• Collaborate across functions and with external partners to address challenges and ensure timely delivery.

Skills

SolidWorks

GD&T

Design for manufacturing

Problem-solving

Verbal and written communication

Electrical safety standards

Microsoft Office

Visio

Collaboration tools

Education

Bachelor’s degree in Mechanical Engineering

Tools

SolidWorks

Visio

Microsoft Office

Job description

Advanced Sterilization Products, Inc. seeks an experienced Senior Mechanical Engineer to plan and execute mechanical design and development for complex medical device components and subsystems.

You will independently create 3D models, detailed drawings, and specifications with GD&T, and develop test protocols to validate performance while ensuring regulatory compliance. The role requires a strong background in regulated environments, solid proficiency in SolidWorks and design-for-manufacturing,