Manufacturing Engineer II

Manufacturing Engineer

We are seeking a Manufacturing Engineer to support the development, optimization, and validation of manufacturing processes within a regulated production environment. This role is responsible for improving manufacturing efficiency, product quality, and overall process performance while collaborating closely with Operations, Quality, R&D, and Supply Chain teams. The ideal candidate is a hands-on problem solver who thrives in a fast-paced environment and is passionate about continuous improvement.

Key Responsibilities

• Develop, implement, and maintain manufacturing processes, procedures, and supporting documentation.
• Design and execute process validations, including IQ, OQ, and PQ activities, to ensure compliance with quality and regulatory requirements.
• Evaluate existing processes and identify opportunities to improve product quality, reduce costs, increase throughput, and shorten cycle times.
• Lead process characterization activities, including Design of Experiments (DOE), data analysis, and performance evaluations.
• Investigate and disposition Non-Conformance Reports (NCRs) and support Corrective and Preventive Action (CAPA) initiatives.
• Recommend, evaluate, and support the acquisition and implementation of manufacturing equipment and tooling.
• Develop production floor layouts and manufacturing workflows to improve operational efficiency and scalability.
• Collaborate with R&D teams to ensure manufacturability of new products and successfully transfer designs into production.
• Work closely with production personnel, including assemblers, supervisors, and team leads, to troubleshoot manufacturing issues and implement solutions.
• Coordinate with suppliers, contractors, and external partners to develop and deploy new manufacturing technologies and processes.
• Utilize data-driven methodologies to improve process capability, reliability, and consistency.
• Facilitate clear communication and collaboration across cross-functional teams to ensure project success.
• Support continuous improvement initiatives focused on safety, quality, delivery, and cost objectives.
• Communicate business risks, opportunities, and project updates to management as required.

Qualifications

• Bachelor's degree in Manufacturing Engineering, Mechanical Engineering, Industrial Engineering, Biomedical Engineering, or a related technical discipline.
• Experience in a manufacturing, medical device, pharmaceutical, or highly regulated production environment preferred.
• Knowledge of process validation methodologies, including IQ/OQ/PQ protocol development and execution.
• Experience with root cause analysis, CAPA investigations, NCR management, and continuous improvement initiatives.
• Familiarity with statistical analysis tools and Design of Experiments (DOE).
• Strong problem-solving, analytical, and troubleshooting skills.
• Excellent written and verbal communication abilities.
• Ability to effectively collaborate with cross-functional teams and production personnel.
• Experience with Lean Manufacturing, Six Sigma, or other process improvement methodologies is a plus.

Preferred Skills

• Process development and optimization
• Equipment qualification and validation
• Regulatory and quality compliance
• Statistical analysis and data interpretation
• Technical documentation and report writing
• Project management and cross-functional leadership

What You'll Bring

• A continuous improvement mindset and passion for manufacturing excellence.
• The ability to balance technical expertise with practical, shop-floor execution.
• Strong attention to detail and commitment to quality.
• A collaborative approach to solving complex manufacturing challenges.

This role offers an opportunity to directly impact product quality, operational efficiency, and manufacturing innovation while working alongside a highly collaborative engineering and operations team.