Job Description
Title: Sr. R&D Mechanical Engineer
Location: Pleasanton, CA 94588
Duration: 6 Months (10/26/2026 to 04/30/2027)
Position Summary
Provides technical leadership in sustaining products for design, verification, investigation, reliability improvement of complex Class II and Class III medical devices, including Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, and associated electromechanical systems. This individual serves as a subject matter expert responsible for leading complex technical investigations, driving product improvements, influencing engineering strategy, and solving challenging system-level problems throughout the product lifecycle. The role requires extensive collaboration across R&D, Quality, Regulatory, Manufacturing, Operations, and Supplier teams to ensure product safety, reliability, compliance, and performance.
Responsibilities:
Minimum Qualifications
Preferred Qualifications
Location: Pleasanton, CA 94588
Duration: 6 Months (10/26/2026 to 04/30/2027)
Position Summary
Provides technical leadership in sustaining products for design, verification, investigation, reliability improvement of complex Class II and Class III medical devices, including Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, and associated electromechanical systems. This individual serves as a subject matter expert responsible for leading complex technical investigations, driving product improvements, influencing engineering strategy, and solving challenging system-level problems throughout the product lifecycle. The role requires extensive collaboration across R&D, Quality, Regulatory, Manufacturing, Operations, and Supplier teams to ensure product safety, reliability, compliance, and performance.
Responsibilities:
- Provide technical leadership across multiple sustaining engineering initiatives involving Class II and Class III medical devices.
- Lead complex technical investigations associated with product performance, complaints, CAPAs, nonconformances, and field issues using structured root cause analysis methodologies.
- Research, develop, test, and sustain mechanical and electromechanical systems used in ventricular assist devices, extracorporeal blood pumps, oxygenators, and related cardiovascular products.
- Drive cross-functional efforts to identify, assess, and implement product, process, and reliability improvements throughout the product lifecycle
- Apply experimental, analytical, empirical, and numerical methods to evaluate product performance, investigate failures, and support engineering decisions.
- Develop test strategies, test methods, and protocols to evaluate system, subsystem, and component performance against product requirements.
- Design, develop, qualify, and validate equipment and fixtures used for engineering verification, reliability testing, and failure analysis activities.
- Identify technical risks and drive mitigation strategies throughout product development and sustaining activities.
- Analyze complaint, post-market surveillance, manufacturing, and reliability data to identify trends and drive continuous improvement initiatives.
- Create and review engineering drawings and specifications to ensure appropriate dimensioning, tolerancing, manufacturability, and assembly requirements.
- Perform and review tolerance analyses and engineering stack-ups to assess product robustness and manufacturability.
- Provide expertise in GD&T and mechanical system design principles.
- Support design reviews and provide technical guidance to engineers across multiple disciplines.
- Mentor and develop engineers through technical coaching, design reviews, and problem-solving activities.
- Evaluate manufacturing processes including precision machining, injection molding, silicone molding, extrusion, laser welding, ultrasonic welding, bonding, and mechanical assembly methods.
- Support supplier selection, qualification, and technical evaluations, including assessments of manufacturing capability, capacity, process controls, and quality systems.
- Collaborate with regulatory, quality, and clinical teams to support submissions, audits, inspections, and responses to regulatory inquiries.
- Ensure compliance with FDA regulations, international standards, company procedures, Quality Management System requirements, and applicable regulatory requirements.
- Support company initiatives as directed by management and contribute to continuous improvement of engineering processes, product quality, and operational excellence. ---
Minimum Qualifications
- Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.
- 15+ years of progressively increasing engineering responsibility supporting Class II and/or Class III medical devices, including product development, sustaining engineering, verification and validation, manufacturing support, and risk management activities.
- Demonstrated technical leadership of complex cross-functional programs and ability to influence technical decisions without direct authority.
- Strong understanding of FDA Design Controls, 21 CFR Part 820, product lifecycle management, and medical device development processes.
- Experience leading complex technical investigations and root cause analyses.
- Expertise in mechanical design, tolerance analysis, GD&T, materials, manufacturing processes, and assembly methods.
- Experience with risk management principles and methodologies, including FMEA analysis.
- Strong written, verbal, presentation, and technical communication skills.
- Ability to effectively communicate with engineers, management, auditors, regulators, suppliers, and customers.
- Ability to travel approximately 10%, including domestic and occasional international travel. ---
Preferred Qualifications
- Master's degree in Mechanical Engineering, Biomedical Engineering, or related discipline
- Experience with ventricular assist devices (VADs), extracorporeal blood pumps, oxygenators, cardiovascular implants, or other implantable Class III medical devices.
- Experience supporting post-market surveillance activities, complaint investigations, CAPAs, and product reliability initiatives.
- Experience with reliability engineering, accelerated life testing, fatigue analysis, and statistical data analysis.
- Experience with medium- to high-volume medical device manufacturing environments.
- Experience with CAD systems, Design of Experiments (DOE), SPC, Six Sigma, and project management methodologies.
- Knowledge of ISO 13485, ISO 14971, EU MDR, and other applicable medical device standards and regulations.
- 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.
- Possiblity to extend and/or convert but no guarantees.
Numbers & Facts
| Location | Pleasanton, CA |
| Industry | Staffing/Employment Agencies |
| Salary | $80 |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | http://www.lancesoft.com/ |
About Company
We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc).
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.
Skills
- Analysis Skillsunmatched
- Biomedical Engineeringunmatched
- CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing)unmatched
- Cardiovascularunmatched
- Clinical Supportunmatched
- Coachingunmatched
- Code of Federal Regulationsunmatched
- Communication Skillsunmatched
- Continuous Improvementunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Design Verificationunmatched
- Electrical Engineeringunmatched
- Electromechanical Systemsunmatched
- Engineering Drawingunmatched
- Experiment Designunmatched
- Extrusionunmatched
- FDA (Food and Drug Administration)unmatched
- FDA Requirementsunmatched
- Failure Analysisunmatched
- Failure Mode and Effects Analysis (FMEA)unmatched
- Functional Programming Languagesunmatched
- Geometric Dimensioning and Tolerancingunmatched
- Healthcare Qualityunmatched
- ISO (International Organization for Standardization)unmatched
- Implantsunmatched
- Injection Moldingunmatched
- Leadershipunmatched
- Machiningunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Analysisunmatched
- Manufacturing Assemblyunmatched
- Manufacturing Engineeringunmatched
- Manufacturing Operationsunmatched
- Manufacturing Requirementsunmatched
- Manufacturing/Industrial Processesunmatched
- Mechanical Assemblyunmatched
- Mechanical Designunmatched
- Mechanical Engineeringunmatched
- Mechanical Testingunmatched
- Medical Equipmentunmatched
- Medical Protocolsunmatched
- Mentoringunmatched
- Molding Processesunmatched
- Numerical Analysisunmatched
- Polymersunmatched
- Presentation/Verbal Skillsunmatched
- Problem Solving Skillsunmatched
- Process Control Engineeringunmatched
- Process Improvementunmatched
- Product Designunmatched
- Product Developmentunmatched
- Product Lifecycleunmatched
- Product Lifecycle Managementunmatched
- Product Programsunmatched
- Product Safetyunmatched
- Product Testingunmatched
- Project/Program Managementunmatched
- Protocol Analysisunmatched
- Pumpsunmatched
- Quality Assurance Methodologyunmatched
- Quality Managementunmatched
- Quality System Requirements (QSR)unmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Regulatory Requirementsunmatched
- Reliability Engineeringunmatched
- Reliability Testingunmatched
- Research & Development (R&D)unmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Root Cause Analysisunmatched
- Six Sigmaunmatched
- Statisticsunmatched
- Strategic Planningunmatched
- Structured Analysisunmatched
- Surveillanceunmatched
- Technical Analysisunmatched
- Technical Leadershipunmatched
- Technical Presentationunmatched
- Technical Supportunmatched
- Technical/Engineering Designunmatched
- Test Plan/Scheduleunmatched
- Test Strategyunmatched
- Testingunmatched
- Tolerance Analysisunmatched
- Trend Analysisunmatched
- United States Department of Energy (DOE)unmatched
- Validation Testingunmatched
- Vendor/Supplier Evaluationunmatched
- Vendor/Supplier Selectionunmatched
- Verification Engineeringunmatched
- Weldingunmatched
- Willing to Travelunmatched
- Writing Skillsunmatched
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