Engineer
Engineering
Bio-Medical
$ 45 - $ 53 / Hour
location_onSan diego, California
acuteContractor
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Your Role
Akkodis is seeking an Engineer for a Contract with a client in San Diego, CA. The ideal candidate will lead end-to-end validation activities by independently authoring and executing protocols while ensuring compliance, driving risk-based validation strategies, and supporting audit readiness.
Rate Range: $45/Hour to $53/Hour; The rate may be negotiable based on experience, education, geographic location, and other factors.
Engineer Job Responsibilities include:
Independently author, review, and execute validation protocols (IQ/OQ/PQ, CSV, system validation).
Manage end-to-end V&V lifecycle including protocol development, execution, reporting, and defect resolution.
Ensure compliance with FDA (21 CFR Part 820), ISO 13485, and risk management standards (ISO 14971).
Provide SME-level guidance on validation strategy and risk-based validation approaches.
Collaborate with cross-functional teams (R&D, Quality, Manufacturing, Regulatory) to support validation activities.
Maintain audit readiness by ensuring accurate documentation and supporting regulatory inspections.
Required Qualifications:
Bachelor's degree in engineering, Biomedical, Life Sciences, or a related field.
8-12+ years of experience in validation and verification (V&V) within the medical device industry.
Strong expertise in authoring and executing validation protocols (IQ/OQ/PQ, CSV) with deep knowledge of FDA (21 CFR Part 820), ISO 13485, and risk management (ISO 14971).
Proven SME experience in managing large-scale validation programs, ensuring audit readiness, and driving risk-based validation strategies in regulated environments.
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 Deep.Kumar@akkodisgroup.com.
Pay Details: $45.00 to $53.00 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:
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: 1636471
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