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Manufacturing Engineer II
Position OverviewWe are seeking an experienced Manufacturing Engineer with a strong background in Class III medical device manufacturing. The role is focused on ensuring compliant, efficient, and validated manufacturing processes while supporting product quality, regulatory requirements, and continuous improvement initiatives. The ideal candidate will have proven expertise in lean, Six Sigma, and GMP methodologies and will play a key role in supporting multiple projects and cross-functional teams.Key Responsibilities
- Develop, implement, and optimize manufacturing processes in compliance with FDA, ISO 13485, and GMP regulations.
- Lead process validations (IQ, OQ, PQ) and ensure proper documentation.
- Conduct risk assessments (PFMEA) and establish effective process controls.
- Support new product introduction (NPI) ensuring manufacturability and scalability.
- Collaborate with cross-functional teams, suppliers, and stakeholders to meet project objectives.
- Manage project timelines, balancing multiple priorities across different projects.
- Support supplier change management and ensure smooth integration into manufacturing.
- Troubleshoot and resolve production issues through structured problem-solving and root cause analysis.
- Implement lean manufacturing, Six Sigma, and continuous improvement initiatives to enhance efficiency and reduce costs.
- Ensure compliance with safety, quality, and regulatory requirements at all times.
Must-Have Qualifications
- Bachelor’s degree in Mechanical Engineering, Manufacturing Engineering, Biomedical Engineering, or related discipline.
- 5–6 years of experience in manufacturing engineering for Class III medical devices.
- Strong knowledge of FDA regulations, ISO 13485, GMP, and risk management standards (ISO 14971).
- Hands-on experience with:
- Process validation (IQ/OQ/PQ)
- Risk assessment (PFMEA)
- Process controls and CAPA
- Proven ability to work with internal and external stakeholders, managing expectations and ensuring alignment.
- Demonstrated experience in project management, meeting deadlines, and supporting multiple projects simultaneously.
Nice-to-Have Qualifications
- Lean Six Sigma certification (Green Belt or higher).
- Familiarity with automation, robotics, and advanced manufacturing technologies.
- Proficiency in CAD tools and ERP/MRP systems (e.g., SAP, Oracle).
- Experience with medical device packaging, labeling, and sterilization validation.
Job Type: Contract - Onsite
Job Location: Sylmar CA
Job Posted date: 12-09-2025
Job Category: Non-IT Jobs