Mechanical Engineer V

Mechanical Engineer

Performs complex activities in the testing and sustaining of class II and class III mechanical circulatory support products including Ventricular Assist Devices (VADs) extracorporeal blood pumps and oxygenators. Provides technical solutions to a wide range of difficult problems. Exercises considerable latitude in determining technical objectives and solutions of assignments.

Research, test, and sustain electromechanical devices for VAD applications. Work with cross-functional teams for development of new products and improvement to existing products driven by corrective and preventative actions (CAPA). Use experimental, empirical, and numerical analysis to evaluate designs. Develop and qualify IQ/OQ fixtures/equipment for verification testing. Investigate issues and identify root causes in complex systems where analysis of situations or data requires an in-depth evaluation of various factors. Identify and mitigate technical risks. Create/review technical drawings for appropriate assembly dimensioning and tolerancing. Knowledgeable in GD&T. Able to review/create tolerance analysis of existing systems. Understands complex machined parts, injection molded parts, extrusions, molding of silicone, and a wide range of assembly techniques (laser welding, ultrasonic welding, bonding, mechanical joining). Experience with risk management (FMEAs). Aid in vendor evaluations such as manufacturing capability and capacity, engineering support, and quality controls. Complies with FDA regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors. Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.

Minimum Qualifications: B.S. in Mechanical, Biomedical, or Manufacturing Engineering. 8 years engineering experience including product development, process development, risk assessment, and VV verification related to class II/III medical devices. Industry experience with FDA design controls (21 CFR 820.30). Strong communication and presentation skills (e.g., versatility communicating with peers, management, auditors/regulators, and customers). Ability to travel approximately 10% primarily in the US but may include international.

Preferred Qualifications: Design and VV of class II/III electromechanical medical devices such as VADs, extracorporeal blood pumps, oxygenators, or other implantable devices. Experience with medium to high volume medical device manufacturing. Experience with a variety of manufacturing processes and designing for manufacturability. Industry experience with EU MDR, ISO 13485, and standards for medical devices (e.g., biocompatibility, sterilization, labeling, packaging, etc.). Experience with CAD design, SPC/six sigma, DOE, and project management.

This is a Contract position based out of Pleasanton, CA. The pay range for this position is $40.00/hr. 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 fully onsite position in Pleasanton, CA. Application Deadline: This position is anticipated to close on Nov 27, 2025. 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 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. 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 due to a disability, please email actatalentaccommodation@actalentservices.com for other accommodation options.