Job Description

Hiring: Mechanical Engineer - Medical Device

Location: Santa Clara, CA 100% Onsite

Duration: 6 12+ Months

Employment Type: W2 Contract

Rate: $48 $52/hr W2

Experience: 7+ Years

Position Overview:

We are seeking experienced Mechanical Engineers to support product development, sustaining engineering, testing, validation, and lifecycle management activities within the medical device industry.

The ideal candidate will have strong experience in medical device product development, design controls, hands-on device testing, prototype development, SolidWorks, fixture design, and cross-functional collaboration within a regulated environment.

Key Responsibilities:

• Lead product sustaining, lifecycle management, CAPA, change-related, and design initiatives
• Support product development activities from concept through commercialization
• Perform hands-on device testing, troubleshooting, and prototype development
• Develop and execute test protocols and technical reports for medical device evaluation
• Develop clinically relevant bench-top test models and methods for device performance evaluation
• Collaborate with Manufacturing, Quality, Regulatory, Engineering, and other cross-functional teams
• Support design verification and feasibility activities using appropriate statistical methodologies
• Analyze test data using statistical techniques and communicate results to cross-functional teams
• Manage Design Control activities and ensure project deliverables comply with applicable SOPs and regulatory requirements
• Maintain and support Design History File (DHF) documentation
• Support laboratory equipment IQ/OQ, preventive maintenance, and calibration activities
• Identify technical risks, establish priorities, and support timely resolution of engineering issues
• Support product and process improvements within a high-volume manufacturing environment
• Provide technical leadership for engineering initiatives of varying scope and complexity

Required / Preferred Qualifications:

• Minimum 7 years of experience in the medical device industry
• Bachelor's degree in Mechanical Engineering, Manufacturing Engineering, Bioengineering, Industrial Engineering, or related technical field preferred
• Advanced working knowledge of SolidWorks and fixture design
• Experience with medical device Design Control and Design History File (DHF) requirements
• Hands-on experience with device testing, troubleshooting, and prototype development
• Experience with IQ/OQ of laboratory equipment, preventive maintenance, and calibration
• Experience with product concept development and design requirements
• Working knowledge of DOE, ANOVA, and statistical study methodologies
• Familiarity with GMP, QMS, FDA, and international regulatory requirements
• Experience in a high-volume production environment preferred
• Experience with cardiovascular catheter delivery systems or equivalent medical devices is a plus
• Experience with IDE, PMA, and Class III medical devices is preferred
• Familiarity with Agile is a plus
• Strong written, verbal, presentation, and cross-functional communication skills
• Strong mechanical aptitude with the ability to support design and problem resolution

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