Mechanical Engineer V

Actalent • Pleasanton, CA • 34min ago

Actalent is hiring for a Mechanical Engineer 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 - $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)

Workplace Type

This is a fully onsite position in Pleasanton,CA.

Application Deadline

This position is anticipated to close on Nov 27, 2025.

Google • Mountain View, CA • 1d ago

IT & Engineering

Mechanical Test Engineer, Platforms Infrastructure corporatefare_ Google place Mountain View, CA, USA Mid Experience driving progress, solving problems, and mentoring more junior team members; deeper expertise and applie...

1d ago

Go to Apply

Senior Data Scientist, Product, Google Play, Ads

Google • Mountain View, CA • 1d ago

IT & Engineering

Senior Data Scientist, Product, Google Play, Ads corporatefare_ Google place Mountain View, CA, USA Mid Experience driving progress, solving problems, and mentoring more junior team members; deeper expertise and applied...

1d ago

Go to Apply

Research Data Scientist, Search Quality

Google • Mountain View, CA • 1d ago

IT & Engineering

Research Data Scientist, Search Quality corporatefare_ Google place Mountain View, CA, USA; New York, NY, USA Mid Experience driving progress, solving problems, and mentoring more junior team members; deeper expertise an...

1d ago

Go to Apply

Architect for Data and AI Engines

Oracle • Redwood City, CA • 1d ago

IT & Engineering

Job Description Design, develop, troubleshoot and debug software programs for databases, applications, tools, networks etc. AI and Data Management Architect Team: AI & Data Platform Engineering Summary: Are you ready...

1d ago

Go to Apply

Subscribe to get new jobs sent directly to you
(no charge, cancel anytime)

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.