Sr. Mechanical Engineer

Job Title: Sr. R&D Mechanical Engineer

Job Description

We are seeking a Research and Development Mechanical Engineer to provide technical leadership in sustaining and improving complex Class II and Class III medical devices. This role involves working with Ventricular Assist Devices (VADs), extracorporeal blood pumps, oxygenators, and associated electromechanical systems. The successful candidate will lead technical investigations, drive product improvements, and influence engineering strategy to solve challenging system-level problems throughout the product lifecycle. Collaboration across R&D, Quality, Regulatory, Manufacturing Operations, and Supplier teams is essential 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.

Essential Skills

• 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.
• Excellent 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.

Additional Skills & 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 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.

Work Environment

The position involves working in a multidisciplinary engineering environment with a focus on medical devices. The role may require travel up to 10%, including domestic and occasional international trips. The work involves collaboration with various departments and adherence to regulatory standards to ensure product quality and compliance.

This is a Contract position based out of Pleasanton, CA.

The pay range for this position is $90.00 - $92.00/hr.

Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following: Medical, dental & vision Critical Illness, Accident, and Hospital 401(k) Retirement Plan Pre-tax and Roth post-tax contributions available Life Insurance (Voluntary Life & AD&D for the employee and dependents) Short and long-term disability Health Spending Account (HSA) Transportation benefits Employee Assistance Program Time Off/Leave (PTO, Vacation or Sick Leave)

This is a Contract position based out of Pleasanton, CA.

This position is anticipated to close on Oct 21, 2026.

This is a fully onsite position in Pleasanton,CA.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com for other accommodation options.

San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.

Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.