Engineer

Engineer

Health Care

Regulatory

$ 37 - $ 44 / Hour

location_onSanta Clara, California

acuteContractor

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Your Role

Akkodis is seeking an Engineer for a Contract with a client in Santa Clara, CA. The ideal candidate with experience leading design transfer, risk management, and quality assurance activities to ensure regulatory compliance and product integrity throughout the product lifecycle.

Rate Range: $37/hour to $44/hour; The rate may be negotiable based on experience, education, geographic location, and other factors.

Engineer Job Responsibilities include:

• Lead design transfer and production support activities to ensure medical devices are successfully transitioned into manufacturing while maintaining regulatory compliance.

• Manage quality systems activities, including Non-Conformance (NC) investigations, CAPA implementation, and continuous improvement initiatives.

• Develop, maintain, and review risk management documentation, including FMEAs and risk assessments, in compliance with ISO 14971 requirements.

• Support manufacturing qualifications (IQ/OQ/PQ), process validations, and issue resolution to ensure product quality and reliability.

• Collaborate with cross-functional teams across R&D, Operations, Quality, and Regulatory Affairs to deliver compliant and manufacturable medical device solutions.

• Support internal and external audits, regulatory inspections, and Quality Management System (QMS) activities while ensuring compliance with ISO 13485, FDA 21 CFR Part 820, MDD, and MDR requirements.

Required Qualifications:

• Bachelor's degree in biomedical engineering, Mechanical Engineering, Electrical Engineering, Quality Engineering, Life Sciences, or a related technical discipline.

• 8+ years of experience in Medical Device Quality, Compliance, Quality Systems, or Regulatory Affairs within FDA-regulated environments.

• Strong expertise in Medical Device Quality Systems, including ISO 13485, FDA 21 CFR Part 820, Design Transfer, CAPA, Non-Conformance Management, and internal/external audits.

• Proven experience in Medical Device Risk Management (ISO 14971), FMEA methodologies, statistical analysis, manufacturing qualifications (IQ/OQ/PQ), and supporting MDD/MDR regulatory compliance activities.

If you are interested in this role, then please click APPLY NOW. For other opportunities available at Akkodis, or any questions, feel free to contact me at Shashank.Tewari@akkodisgroup.com.

Pay Details: $37.00 to $44.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, 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.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://www.akkodis.com/en/us/candidate-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

Massachusetts Candidates Only: 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.

Ref: 1639002

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