Apply on Employer Site

Myomo, Inc. · 1 day ago

Sr. Manufacturing Engineer

Burlington, MA

Full-time

Onsite

Mid, Senior Level

$115K/yr - $120K/yr

5+ years exp

Myomo, Inc. is a company that develops and markets innovative powered arm braces to restore function in individuals with neurological impairments. The Senior Manufacturing Engineer will oversee the development and optimization of manufacturing processes, ensuring compliance with medical device regulations and facilitating the transition from design to production.

BiotechnologyHealth CareMedical Device

Responsibilities

Facilitate 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

Spearhead the implementation of efficient, scalable manufacturing processes and workflows for the introduction of novel medical devices, drawing from expertise in rapid-prototyping and volume manufacturing techniques

Ensure that all manufacturing documentation including work instructions, process flow diagrams, and validation protocols, is thoroughly developed and maintained

Liaise with suppliers and vendors to coordinate the timely delivery of critical components and materials, while maintaining traceability and quality control

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 implement corrective and preventive actions in response to non-conformities or customer feedback

Lead cost-saving initiatives and projects, optimizing resource utilization and driving operational excellence, while maintaining the highest standards of quality and compliance

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

Medical device manufacturingSolidWorksISO 1348521 CFR 8203D printing technologyProcess improvementAnalytical 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 in SolidWorks

Proven track record of successful manufacturing process flow design and implementation, with a strong understanding of quality systems and regulatory compliance requirements

Solid experience utilizing 3D printing technology

Hands-on experience working in a highly regulated medical device environment, with a comprehensive understanding of ISO 13485 and 21 CFR 820 requirements

Exceptional problem-solving and analytical skills, with a keen eye for process improvement opportunities

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