Process Development Engineer

Our client is a leading innovator in the field of medical device manufacturing, dedicated to enhancing the quality of healthcare through cutting-edge technologies. We are seeking a highly motivated and talented Medical Device Process Engineer to join our dynamic team. As a Medical Device Process Engineer, you will play a pivotal role in developing and optimizing manufacturing processes to ensure the production of high-quality medical devices that improve patients' live

• Process Development: Develop and optimize manufacturing processes for medical devices, including new product introductions, process improvements, and cost-reduction initiatives.
• Ensure that processes are efficient, scalable, and compliant with industry standards and regulatory requirements.
• Continuous Improvement: Lead and participate in cross-functional teams to identify opportunities for process enhancements, cost reductions, and efficiency improvements.
• Implement best practices and lean manufacturing principles to streamline operations.
• Design for Manufacturability (DFM): Collaborate with R&D and product design teams to provide input on design choices that enhance manufacturability, reduce production complexity, and improve product quality.
• Equipment and Tooling: Evaluate, select, and implement manufacturing equipment, tools, and fixtures to support production needs.
• Oversee equipment maintenance and calibration activities.
• Validation and Verification: Lead process validation activities, including protocol development, execution, and report writing.
• Ensure that manufacturing processes are validated and meet established quality criteria.
• Documentation Control: Maintain accurate and up-to-date manufacturing documentation, including Standard Operating Procedures (SOPs), work instructions, and batch records.

• Bachelor's degree in engineering or a related field; advanced degree preferred.
• 3+ years of experience in medical device manufacturing or a similar regulated industry.
• Proficiency in process development, process optimization, and quality systems.
• Strong knowledge of FDA regulations and ISO standards (e.g., ISO 13485).
• Excellent problem-solving and analytical skills.
• Proficiency in data analysis and statistical tools.
• Strong communication and teamwork skills.
• Project management experience is a plus.