Senior Mechanical Design Engineer

Position : Senior Mechanical Engineer

Location: Pleasanton, CA 94588

Duration: 6 Months (Potential Extension or Conversion)

Work Schedule: 8:00 AM – 5:00 PM

Work Arrangement: Onsite

Position Summary

• We are seeking an experienced Sr. R&D Mechanical Engineer to provide technical leadership in sustaining engineering, product verification and validation, failure investigation, and reliability improvement for complex Class II and Class III medical devices.
• The ideal candidate will have extensive experience in mechanical and electromechanical systems, medical device product development, root cause analysis, and regulatory compliance. This role involves leading complex technical investigations, driving product improvements, and collaborating with cross-functional teams to ensure product safety, reliability, quality, and performance throughout the product lifecycle.
• Experience with cardiovascular medical devices, ventricular assist devices (VADs), blood pumps, oxygenators, or other implantable medical devices is highly desirable.

Key Responsibilities

• Lead sustaining engineering initiatives for Class II and Class III medical devices, focusing on product performance, reliability, and continuous improvement.
• Drive complex technical investigations involving product complaints, CAPAs, nonconformances, and field failures using structured root cause analysis methodologies.
• Develop and execute verification strategies, test methods, and protocols to evaluate mechanical and electromechanical systems.
• Design, develop, qualify, and validate test fixtures and equipment for engineering verification, reliability testing, and failure analysis.
• Analyze product performance, manufacturing, complaint, and reliability data to identify trends and implement corrective actions.
• Create and review engineering drawings, specifications, GD&T requirements, and tolerance stack-up analyses.
• Evaluate materials, manufacturing processes, and assembly methods to improve product quality, manufacturability, and reliability.
• Identify technical risks and develop mitigation strategies using FMEA and other risk management methodologies.
• Collaborate with R&D, Quality, Regulatory, Manufacturing, Operations, Clinical, and Supplier teams to resolve technical challenges.
• Support supplier evaluations, qualification activities, and assessments of manufacturing capabilities and process controls.
• Provide technical guidance and mentorship to engineers through design reviews, technical assessments, and problem-solving activities.
• Ensure compliance with FDA regulations, design controls, applicable industry standards, and Quality Management System requirements.
• Support regulatory submissions, audits, inspections, and continuous improvement initiatives.

Minimum Qualifications

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
• 15+ years of progressively responsible engineering experience supporting Class II and/or Class III medical devices.
• Extensive experience in product development, sustaining engineering, verification and validation, manufacturing support, and risk management.
• Strong knowledge of FDA design controls, 21 CFR Part 820, and medical device product lifecycle processes.
• Proven experience leading complex technical investigations and root cause analysis.
• Expertise in mechanical design, GD&T, tolerance analysis, materials, manufacturing processes, and assembly methods.
• Experience with FMEA and other product risk management methodologies.
• Demonstrated technical leadership and cross-functional collaboration skills.
• Excellent technical documentation, communication, and problem-solving abilities.
• Ability to travel approximately 10%, including occasional domestic and international travel.

Preferred Qualifications

• Master's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Experience with VADs, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.
• Experience with complaint investigations, CAPAs, post-market surveillance, and product reliability improvement.
• Knowledge of reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.
• Experience in medium- to high-volume medical device manufacturing environments.
• Proficiency with CAD systems, Design of Experiments (DOE), Statistical Process Control (SPC), and Six Sigma methodologies.
• Knowledge of ISO 13485, ISO 14971, EU MDR, and other applicable medical device standards.
• Experience working with external manufacturing partners and global suppliers.
• Familiarity with multidisciplinary systems involving electrical components, software-controlled devices, polymers, biomaterials, and biological systems