New Product Introduction Engineer

Akkodis; Irvine (CA); On-site; USD 58,000 - 62,000; Full time

Benefits offered by this job

Medical

Dental

Vision

Life Insurance

Short-Term Disability

401K Plan

Commuter Benefits

Job summary

Akkodis in Irvine, CA seeks a Product Support / CIP Engineer with medical device experience to lead CIP projects that optimize costs and sustain product quality. You will work across R&D, Quality, Manufacturing, and Supply Chain to drive improvements.

The role emphasizes validation activities, design changes, supplier changes, and adherence to FDA and ISO 13485 standards to ensure robust product performance and cost reductions.

Qualifications

• 6–8 years of experience in medical device product support / sustaining / CIP roles.
• Strong experience with change control (ECO, supplier changes)
• Hands-on experience with validation (protocols and reports)
• Experience in cost reduction / continuous improvement projects
• Knowledge of FDA regulations and ISO 13485
• Strong cross-functional communication and coordination skills

Responsibilities

• Lead CIP (cost improvement) projects and drive implementation
• Manage design changes and supplier change control (ECO, CR, etc.)
• Perform cost analysis, budgeting, and feasibility assessments
• Develop and manage project plans, timelines, and deliverables
• Support validation activities (protocols, testing, reports)
• Collaborate with R&D, Quality, Manufacturing, and Supply Chain teams
• Conduct design reviews, risk assessments, and cross-functional meetings
• Ensure compliance with FDA, ISO 13485, and internal quality systems
• Monitor project progress, identify risks, and drive mitigation

Skills

Medical device experience

Change control

Validation protocols

Cost reduction

FDA regulations

Cross-functional communication

Tools

MS Project

PLM systems

FMEA/DOE tools

Job description

We are seeking a Product Support / Continuous Improvement (CIP) Engineer with strong experience in the medical device industry to support cost optimization and sustaining engineering initiatives.

This role involves leading continuous improvement projects, managing design and supplier changes, supporting validation activities, and working closely with cross-functional teams to improve product performance, quality, and cost.

Pay Range: $42/hr. – $45/hr. on W2 (The pay rate may be negotiable based on experience, education, geographic location, and other factors.)

Key Responsibilities:

• Lead CIP (cost improvement) projects and drive implementation
• Manage design changes and supplier change control (ECO, CR, etc.)
• Perform cost analysis, budgeting, and feasibility assessments
• Develop and manage project plans, timelines, and deliverables
• Support validation activities (protocols, testing, reports)
• Collaborate with R&D, Quality, Manufacturing, and Supply Chain teams
• Conduct design reviews, risk assessments, and cross-functional meetings
• Ensure compliance with FDA, ISO 13485, and internal quality systems
• Monitor project progress, identify risks, and drive mitigation

Required Skills & Experience:

• 6–8 years of experience in medical device product support / sustaining / CIP roles
• Strong experience with change control (ECO, supplier changes)
• Hands‑on experience with validation (protocols and reports)
• Experience in cost reduction / continuous improvement projects
• Knowledge of FDA regulations and ISO 13485
• Strong cross‑functional communication and coordination skills

Preferred Qualifications:

• Experience with project planning tools (MS Project)
• Familiarity with FMEA, DOE, or risk management tools
• Exposure to PLM systems and supplier management

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