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Myomo, Inc. · 10 hours ago

Sr. Manufacturing Engineer

Burlington, MA

Full-time

Onsite

Senior Level

5+ years exp

Myomo, Inc. is a company that develops and markets innovative powered arm braces to restore function for individuals with paralysis or weakness. The Senior Manufacturing Engineer will lead the development and optimization of manufacturing processes for orthotic designs, drive continuous improvement initiatives, and collaborate closely with various teams to ensure high-quality production.

BiotechnologyHealth CareMedical Device

Responsibilities

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, drawing from expertise in cost efficient and scalable manufacturing techniques

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

Qualification

Manufacturing process design3D printing technologyProcess validation activitiesMedical device regulationsSolidWorksCOGS reduction projects6 Sigma Green BeltAnalytical skillsProblem-solving skillsCommunication skillsCollaboration skills

Required

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