Mechanical Engineer

Actalent is hiring for a Mechanical Engineer V in Pleasanton, CA!!

POSITION SUMMARY:

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.

RESPONSIBILITIES:

• 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 GDT
• Able to review/create tolerance analysis of existing systems
• Understands complex machined parts injection molded parts extrusions molding of silicone
• 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

Job Type & Location

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

Pay and Benefits

The pay range for this position is $40.00 - $65.00/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)

Workplace Type

This is a fully onsite position in Pleasanton,CA.

Application Deadline

This position is anticipated to close on Dec 9, 2025.

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 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 actalentaccommodation@actalentservices.com for other accommodation options.

Salary : $40 - $65