Job Title: Manufacturing Engineer II

Location: Sylmar, CA 91342 Onsite

Duration: 12 months contract with possible extension

Shift/Schedule: 8:00 AM -5:00 PM/M-F

Overview -

We are seeking a highly skilled Manufacturing Engineer II with proven experience supporting engineering activities for Class III medical devices. This role requires expertise in manufacturing process development, validation (IQ/OQ/PQ), risk assessment, and cross-functional collaboration to deliver high-quality medical device manufacturing solutions.

You will be responsible for leading complex engineering tasks, anticipating challenges, and driving improvements aligned with business goals while ensuring compliance with applicable regulatory standards.

Responsibilities -

• Lead and execute complex manufacturing engineering projects requiring technical expertise and proactive decision-making.
• Support Class III medical device manufacturing in alignment with Lean, Six Sigma, and GMP methodologies.
• Perform process validation activities (IQ/OQ/PQ), root cause analysis, and corrective/preventive actions.
• Ensure manufacturing processes meet safety, quality, and regulatory requirements.
• Collaborate with internal and external stakeholders including suppliers and cross-functional teams.
• Support risk management activities and establish efficient process controls.
• Manage multiple project timelines while maintaining compliance to standards and delivery expectations.
• Conduct peer reviews for processes, validation plans, and technical approach.

Education, Qualifications & Requirements -

• Bachelor of Science in Electrical, Software, Mechanical, or Manufacturing Engineering (or equivalent discipline).

Experience -

• Minimum 5 6 years of experience in Manufacturing Engineering within Class III medical devices

• IQ/OQ/PQ validation
• Risk analysis & process control
• Lean, Six Sigma, GMP manufacturing methods
• Supplier change management
• Excellent organizational, leadership, and communication skills
• Ability to manage multiple projects and cross-functional coordination

Preferred Skills -

• Experience supporting regulatory audits and compliance activities
• Proficiency in continuous improvement initiatives
• Strong analytical and problem-solving mindset