Manufacturing Engineer II

Position Summary:

We are seeking a detail-oriented and innovative Manufacturing Engineer to support the production of high-quality medical devices. This role is responsible for optimizing manufacturing processes, ensuring compliance with regulatory standards, and driving continuous improvement initiatives. The ideal candidate will have experience in medical device manufacturing, validation (IQ/OQ/PQ), and lean methodologies.

Key Responsibilities:

• Develop, implement, and improve manufacturing processes for medical device production.
• Lead and support equipment and process validations (IQ/OQ/PQ) in accordance with FDA and ISO 13485 requirements.
• Collaborate with cross-functional teams including Quality, R&D, and Regulatory Affairs to ensure product and process compliance.
• Analyze manufacturing data to identify trends, root causes, and opportunities for improvement.
• Design and execute experiments using statistical tools (DOE, SPC) to optimize processes.
• Support new product introductions (NPI) and technology transfers into manufacturing.
• Create and maintain manufacturing documentation including work instructions, process flow diagrams, and PFMEAs.
• Lead or participate in CAPA investigations and implementation of corrective actions.
• Drive lean manufacturing initiatives to reduce waste, improve efficiency, and enhance product quality.
• Ensure compliance with Good Manufacturing Practices (GMP) and applicable regulatory standards.

Qualifications:

• Bachelor's degree in Mechanical, Biomedical, Industrial Engineering, or related field.
• 3+ years of experience in a manufacturing engineering role within the medical device industry.
• Strong knowledge of FDA regulations, ISO 13485, and GMP.
• Experience with validation protocols (IQ/OQ/PQ) and statistical analysis tools.
• Proficiency in CAD software and manufacturing documentation systems.
• Excellent problem-solving, communication, and project management skills.
• Lean Six Sigma certification is a plus.

Preferred Skills:

• Experience with automation and robotics in manufacturing.
• Familiarity with ERP systems (e.g., SAP, Oracle).
• Knowledge of cleanroom operations and sterile packaging processes.
• Ability to work in a fast-paced, regulated environment.