Mechanical Lead

Position Title: Mechanical Engineering Lead

Location: Irvine, CA(contract- open for fulltime)

Pay Range: $40- $49/hr on w2

(The rate may be negotiable based on experience, education, geographic location, and other factors)

Duration: 12+ months (with possible extension)

Job Description:

·We are seeking a highly experienced Mechanical Engineering Lead with a strong background in medical device product development. The ideal candidate will lead design, development, and continuous improvement initiatives while collaborating with cross-functional teams.

Key Responsibilities

• Lead mechanical design and development activities for medical devices
• Drive Continuous Improvement (CIP) projects and cost optimization initiatives
• Develop project plans, timelines, and execution strategies
• Collaborate with R&D, Quality, Manufacturing, and suppliers
• Perform design reviews, testing, and validation activities
• Manage supplier changes and engineering change requests
• Support process validation, documentation, and regulatory compliance
• Present technical updates and project status to stakeholders

Required Skills & Qualifications

• Bachelor’s degree in Mechanical Engineering or related field
• 5–10 years of experience in medical device industry
• Strong knowledge of ISO 13485, ISO 14971, FDA regulations (21 CFR 820)
• Hands-on experience with SolidWorks/CAD tools
• Experience with product design, validation, and risk management
• Knowledge of plastic molding, packaging, labeling, and 510(k) submissions
• Familiarity with statistical tools (Minitab preferred)
• Strong project management and communication skills

Preferred Qualifications

• Six Sigma certification
• Experience in supplier management and process improvement

If you feel this is not something that you are currently interested in, but know of someone, that might be, please share the details with them or let me know their details so I can reach out to them!

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