Mechanical Engineer

Akkodi's is seeking a Sr. R&D Mechanical Engineer for a 6 Months contract position with a client located in Pleasanton, CA 94588. 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 comes as a plus.

Job Title : Sr. R&D Mechanical Engineer

Location : Pleasanton, CA 94588

Duration : 6 Months

Pay Range: $80/hr - $85/hour on w2 (without benefits); the rate may be negotiable based on experience, education, geographic location and other factors.

Minimum Qualifications:

• Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Manufacturing Engineering, or related engineering discipline.
• 10 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.

If you are interested in this Sr. R&D Mechanical Engineer – 6 Months Contract position with a client located in Pleasanton, CA 94588 then please click APPLY NOW. For other opportunities available at Akkodis go to www.akkodis.com .If you have questions about the position, please contact Mohammed Ateequddin at mohammed.ateeq@akkodisgroup.com

Equal Opportunity Employer/Veterans/Disabled

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, an EAP program, commuter benefits, and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable. Disclaimer: These benefit offerings do not apply to client-recruited jobs and jobs that are direct hires to a client.

To read our Candidate Privacy Information Statement, which explains how we will use your information, please visit https://www.akkodis.com/en/privacy-policy.

The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

· The California Fair Chance Act

· Los Angeles City Fair Chance Ordinance

· Los Angeles County Fair Chance Ordinance for Employers

· San Francisco Fair Chance Ordinance.