Senior Onsite Medical Device Test Lab Lead

Bayside Solutions; Santa Clara (CA); On-site; USD 87,000 - 96,000; Full time

Job summary

Bayside Solutions, Inc. in Santa Clara, CA is seeking a Test Lab Manager to lead a medical device mechanical testing laboratory onsite. You will plan, execute, and document static and dynamic tests, schedule equipment maintenance, and ensure regulatory compliance.

Responsibilities include calibration, collaboration with project teams, and maintaining traceable documentation while upholding ISO 13485, FDA QSRs, and related standards to support rapid company growth.

Qualifications

• 5+ years of hands-on experience with mechanical testing equipment and QA/testing
• Proficiency designing test fixtures and handling fabrication
• Experience in preventative maintenance and repair
• Familiarity with ASTM/ISO static and dynamic testing
• Preference for orthopedics and/or spine testing
• Meticulous, process-oriented with traceable documentation for compliance

Responsibilities

• Managing a medical device mechanical testing laboratory
• Planning, execution, and documentation of mechanical testing (static, dynamic)
• Scheduling equipment maintenance and repair
• Supporting regulatory requirements and quality system
• Ensure compliance with ISO 13485, FDA QSRs and related standards

Skills

Mechanical testing

Test fixtures

Preventive maintenance

ASTM/ISO testing

Orthopedics/spine knowledge

Attention to detail

Communication

MS Office

Safety compliance

Regulatory knowledge

Education

BS in Mechanical Engineering

Tools

Instron

MTS

Job description

Bayside Solutions, Inc. in Santa Clara, CA is seeking a Test Lab Manager to lead a medical device mechanical testing laboratory onsite. You will plan, execute, and document static and dynamic tests, schedule equipment maintenance, and ensure regulatory compliance.

Responsibilities include calibration, collaboration with project teams, and maintaining traceable documentation while upholding ISO 13485, FDA QSRs, and related standards to support rapid company growth.