Mechanical Engineer II

Overview

JOB TITLE:
Mechanical Engineer II

LOCATION:

Cypress, CA (Hybrid)
DURATION: 6 months

PAY RANGE: $45 - $55/hr.

• Mechanical Engineering degree (B.S. required) with ≥2 years of mechanical engineering experience in medical devices or regulated industry, including sustaining/manufacturing support.
• Proficiency in mechanical design software (Solid Works), engineering documentation (PLM), GD&T, tolerance analysis, and design control compliance (FDA, ISO 13485).
• Experience with root cause analysis, risk management, and product lifecycle support, including collaborating with cross-functional teams to resolve manufacturing or product issues.

Our client’s Product Development team is seeking a highly skilled Mechanical Engineer to join their Lifecycle (Sustaining) Engineering team. This role focuses on supporting existing products through their lifecycle, ensuring quality, compliance, and continuous improvement while maintaining business continuity. In this role, you will have the opportunity to lead cross-functional projects that keep released medical device products compliant, reliable, cost-effective, and continuously manufacturable.

You ll play a pivotal role within our client’s Lifecycle Engineering (LCE) Center of Excellence, charting the course for the company s capabilities, and collaborating with cross-functional teams. This opportunity offers substantial career growth potential while positively impacting lives through design and technology.

• Provide mechanical engineering & design support for sustaining activities, including, fixture mechanical design, component/material changes, and process improvements for existing products.
• Investigate and resolve product performance issues, manufacturing challenges, and field complaints through root cause analysis and corrective actions.
• Collaborate with cross-functional teams (Quality, Regulatory, Manufacturing, and Supply Chain) ensuring compliance with FDA, ISO 13485, ISO 10993, and other applicable standards.
• Evaluate and qualify alternate components (mechanical/electrical), materials or suppliers to mitigate obsolescence and supply chain risks without compromising product quality or regulatory compliance.
• Create and maintain engineering documentation within PLM system, including drawings, specifications, and change orders, in accordance with design control requirements from development through production.
• Author and execute V&V test plans, protocols, and reports compliant with applicable IEC standards and internal SOPs.
• Participate in risk management activities, including FMEA updates and hazard analysis for design changes.
• Provide technical input for process validation, equipment qualification, and manufacturing transfer activities.
• Serve as a subject matter expert for mechanical design and manufacturing processes within the lifecycle engineering team.

• B.S. in Mechanical Engineering or related field; advanced degree a plus.
• At least 2 years of experience in mechanical engineering within the medical device or regulated industry, manufacturing support a plus.
• Proficiency in design software (e.g., Solid Works) and engineering documentation systems (PLM).
• Demonstrated experience Geometric Dimensioning & Tolerancing (GD&T) and tolerance stack-up analysis (device hardware).
• Strong knowledge of FDA regulations, ISO 13485, and design control principles.
• Demonstrated experience with root cause analysis, risk management, and problem-solving methodologies.
• Understanding printed circuit board (PCB) design and integration with mechanical interfaces used in medical devices a plus.
• Ability to collaborate with manufacturing and quality teams to troubleshoot production issues and implement continuous improvement.
• Basic understanding of manufacturing processes such as injection molding, machining, and assembly.
• Familiarity with Six Sigma, Lean Manufacturing, or other continuous improvement methodologies.
• Understanding of biocompatibility, materials science, including polymers and metals used in medical devices a plus.
• Basic understanding of ERP systems and manufacturing execution systems (MES) a plus

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