To Discuss more about this job opportunity, please reach out to Anwesha Mohapatra (LinkedIn URL -Anwesha Mohapatra - Collabera | LinkedIn), email your updated resume at Email - anwesha.mohapatra@collabera.com. Thank you!

Pay Range: $70/hr to $75/hr

Job Title: Senior Mechanical Engineer

Location: Pleasanton, California 94588

Work Type: Onsite

Contract Duration: 6 Months, with possible extension based on performance and business needs

Job Summary:

We are seeking a highly experienced Senior Mechanical Engineer to provide technical leadership in sustaining complex Class II and Class III medical devices and electromechanical systems. The ideal candidate will lead technical investigations, drive root cause analysis, and implement product reliability and performance improvements throughout the product lifecycle. This role requires expertise in mechanical design, verification and validation, risk management, and medical device manufacturing processes. The engineer will collaborate with cross functional teams to ensure product safety, quality, regulatory compliance, and manufacturing efficiency. Strong technical leadership, problem solving, and communication skills are essential for success in this senior level position.

Key Responsibilities:

• Provide technical leadership across multiple sustaining engineering initiatives involving complex medical devices and electromechanical systems.
• Lead technical investigations related to product complaints, CAPAs, nonconformances, field issues, and product performance using structured root cause analysis methodologies.
• Research, develop, test, and sustain mechanical and electromechanical systems, including cardiovascular devices, blood pumps, and oxygenation systems.
• Drive cross functional initiatives to improve product design, manufacturing processes, reliability, and overall product performance.
• Develop test strategies, test methods, and protocols to evaluate system, subsystem, and component performance against established requirements.
• Design, qualify, and validate equipment and fixtures for engineering verification, reliability testing, and failure analysis.
• Identify technical risks and implement mitigation strategies throughout product development and sustaining engineering activities.
• Analyze complaint data, post market surveillance information, manufacturing trends, and reliability data to identify opportunities for continuous improvement.
• Create and review engineering drawings, specifications, geometric dimensioning and tolerancing requirements, and tolerance stack up analyses.
• Evaluate manufacturing processes, including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly.
• Support supplier selection, qualification, and technical assessments related to manufacturing capabilities, process controls, capacity, and quality systems.
• Collaborate with Quality, Regulatory, Manufacturing, Research and Development, Operations, and Clinical teams to support regulatory submissions, audits, inspections, and compliance activities.
• Provide technical guidance and mentorship to engineers through design reviews, technical coaching, and complex problem solving.
• Ensure compliance with applicable FDA regulations, international standards, quality management system requirements, and internal engineering procedures.

Required Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or a related engineering discipline.
• At least 15 years of progressive engineering experience supporting Class II or Class III medical devices.
• Extensive experience in product development, sustaining engineering, verification and validation, manufacturing support, and risk management.
• Demonstrated experience leading complex cross functional engineering programs and influencing technical decisions without direct authority.
• Strong knowledge of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.
• Proven expertise in complex technical investigations, root cause analysis, mechanical design, materials, manufacturing processes, and assembly methods.
• Strong knowledge of tolerance analysis, geometric dimensioning and tolerancing, and mechanical system design principles.
• Experience with risk management methodologies, including Failure Mode and Effects Analysis.
• Excellent written, verbal, presentation, and technical communication skills.
• Ability to collaborate effectively with engineering teams, management, suppliers, auditors, regulators, and customers.
• Ability to travel approximately 10 percent domestically and occasionally internationally.

Preferred Qualifications:

• Master's degree in Mechanical Engineering, Biomedical Engineering, or a related discipline.
• Experience with ventricular assist devices, extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.
• Experience supporting post market surveillance, complaint investigations, CAPAs, and product reliability improvement initiatives.
• Knowledge of reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.
• Experience in medium to high volume medical device manufacturing environments.
• Experience with computer aided design systems, Design of Experiments, Statistical Process Control, Six Sigma, and project management methodologies.
• Knowledge of ISO 13485, ISO 14971, European Union Medical Device Regulation, and other applicable medical device standards.
• Experience working with external manufacturing partners and global suppliers.
• Exposure to multidisciplinary engineering fields, including electrical systems, software controlled devices, polymers, biomaterials, and biological systems.

Benefits: The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, (paid time , paid sick and safe time , hours of paid vacation time, weeks of paid parental leave, paid holidays annually - AS Applicable)