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The Senior Manufacturing Engineer is a key member of the team responsible for leading the development and optimization of internal manufacturing processes for the next generation of orthotic designs, while providing expert support for sustaining engineering of existing products. This role combines hands-on technical execution with cross-functional leadership, requiring a strong passion for transitioning innovative designs into scalable, high-quality manufacturing solutions. The Senior Manufacturing Engineer drives continuous improvement initiatives, proactively resolves complex production issues, and mentors team members while collaborating closely with design, quality, operations, and supply chain partners. This role requires deep expertise in manufacturing process flow and design, experience with mechatronics and advanced 3D printing technologies, and the ability to influence projects from early concept through full production lifecycle.
Job Responsibility:
Serve as lead Manufacturing Engineering representative to ensure a smooth handoff of new product designs to the manufacturing environment in close collaboration with design and product development teams
ensure full compliance with medical device regulations
Lead Process development and validation efforts for the implementation of efficient, scalable manufacturing processes and workflows for the introduction of novel medical devices
Develop and maintain all manufacturing documentation including work instructions, process flow diagrams, and validation protocols through the development effort
Work closely with Supply Chain team on the identification and selection of appropriate suppliers and vendors to establish the timely delivery of critical components and materials related to new product development meeting delivery, quality and cost targets
Continuously monitor and optimize existing manufacturing processes, enhancing efficiency, quality, and safety with a keen focus on medical device manufacturing best practices
Promptly address and resolve any manufacturing issues, mitigating disruptions to production and ensuring compliance with applicable regulations
Partner with Quality to drive root cause analysis activities, implement corrective and preventive actions in response to non-conformances, CAPA’s and customer complaints
Lead cost-saving initiatives and projects, optimizing resource utilization and driving operational excellence, while maintaining the highest standards of quality and compliance
Identify and lead projects that iterate current product designs to resolve manufacturing issues, enhance quality, production cost and customer satisfaction
Foster a culture of continuous learning and regulatory compliance, providing training and guidance to the manufacturing team on new processes, equipment, and quality systems
Support product launches, continuous improvement projects, and other strategic company initiatives through consistent cross-functional partnership
ultimately ensure a seamless integration of manufacturing requirements
Ensure full compliance with all relevant industry regulations and standards
Requirements:
Bachelor’s degree and at least 5 years of relevant experience in the medical device industry, or Master’s degree and 3+ years of industry experience
3+ years' designing manufacturing fixtures and product design changes in SolidWorks
Proven track record of COGS reduction projects and implementation, with a strong understanding of quality systems and regulatory compliance requirements
Solid experience utilizing 3D printing technology
Exceptional problem-solving and analytical skills utilizing 6 Sigma Green Belt and Minitab tools
Expertise with process validation activities IQ, OQ, PQ, TMV, Design Validation testing
Hands-on experience working in a highly regulated medical device environment, with a comprehensive understanding of ISO 13485 and 21 CFR 820 requirements
Strong commitment to maintaining the highest standards of quality and compliance
Excellent communication and collaboration skills, with the ability to effectively interface with cross-functional teams and external partners, including suppliers and regulatory bodies