Manufacturing Process Engineer- Mechanical

Primary Responsibilities:As a Manufacturing Process Engineer, you will play a vital role in connecting Business Development and Plant Operations, shaping the success of our Medical Devices and Healthcare products. With your in-depth understanding of Mechanical Engineering, manufacturing processes, and mechanical design, you will lead the way in enabling procurement and localization activities during new product inquiries and the initiation of new programs.

• Collaborate closely with Business Development and Plant Operations teams to ensure seamless communication and alignment of manufacturing processes with project goals.
• Apply your extensive knowledge of Mechanical Engineering, manufacturing processes, and mechanical design to create and optimize manufacturing methods for medical devices and healthcare solutions.
• Evaluate current manufacturing processes, identifying opportunities for enhancement in terms of efficiency, quality, and cost-effectiveness.
• Lead the development and implementation of innovative manufacturing techniques to enhance productivity and product quality.
• Troubleshoot and resolve manufacturing issues related to mechanical components, assemblies, and systems.
• Oversee process validation and verification efforts, including designing experiments and analyzing data to ensure robust processes.
• Establish strong relationships with suppliers to ensure a consistent supply of high-quality materials for manufacturing.
• Collaborate with cross-functional teams to successfully introduce new processes and drive continuous improvement initiatives.
• Maintain comprehensive documentation, including work instructions, process flows, and quality standards.
• Stay informed about industry trends, technological advancements, and best practices to drive innovation in manufacturing processes.
• Work closely with RD, product management, and design teams to support the development of new medical devices from concept to market launch.
• Participate in the design control process, ensuring that products meet design specifications, regulatory requirements, and quality standards.
• Collaborate on prototyping, testing, and verification efforts to validate product designs.
• Assist in maintaining compliance with relevant regulatory standards, including FDA, ISO 13485, and other applicable guidelines.

Knowledge and Skill Requirements:Solid expertise in Mechanical Engineering, manufacturing processes, and mechanical design.

• Thorough understanding of medical device manufacturing requirements and industry standards.
• Preferred experience and understanding of sheet metal fabrication and associated processes.
• Strong problem-solving skills with an analytical approach to process optimization.
• Familiarity with quality management principles and methodologies.
• Excellent communication skills to collaborate effectively with cross-functional teams.
• Attention to detail and a commitment to maintaining high-quality standards.
• Proven track record of driving process improvements and achieving tangible results.

Qualifications / Experience:Bachelor's degree in Mechanical Engineering or a related field.

• Minimum of 5 years of experience in Mechanical Engineering, Manufacturing Process Engineering, or a related role.