Manufacturing Engineer Job at Intellectt Inc in California

Hi All,

We are seeking an experienced Manufacturing Engineer II to join our team in supporting Class III medical device manufacturing operations. This role requires a strong background in process validation, risk assessment, and cross-functional collaboration to ensure manufacturing excellence and compliance with regulatory standards.

Job Title: Manufacturing Engineer II

Location: Sylmar, CA – 91342

Duration: 12 Months (Contract)

Key Responsibilities:

• Lead and take ownership of complex technical manufacturing engineering tasks
• Apply expertise in Lean, Six Sigma, and GMP methodologies to optimize manufacturing processes
• Perform and oversee process validations (IQ/OQ/PQ) and ensure compliance with regulatory requirements
• Conduct risk assessments and implement effective process controls
• Collaborate with cross-functional teams, internal stakeholders, and external suppliers to support multiple projects
• Anticipate and identify key issues, recommending creative solutions where precedent may not exist
• Manage project timelines, supplier changes, and technical deliverables to support manufacturing initiatives
• Provide peer review for task approach direction and verification/validation activities

Qualifications:

Must-Have:

• Bachelor’s degree in Electrical, Mechanical, Software, or related Engineering field
• 5–6 years of experience supporting Manufacturing Engineering in Class III medical devices
• Proven expertise in process validation (IQ/OQ/PQ), risk assessment, and process controls
• Strong experience managing project timelines, supplier changes, and cross-functional teams
• Solid understanding of Lean, Six Sigma, and GMP methodologies

Nice-to-Have:

• Advanced certifications in Lean, Six Sigma, or related fields
• Experience with automation or advanced manufacturing technologies in medical devices

Additional Information:

Industry Experience: Medical Device only (Class III required). Candidates from adjacent industries (e.g., pharma, aerospace) will not be considered. Role Expectation: Ability to demonstrate proactive leadership, creative problem solving, and effective communication across stakeholders.