Sr. Design Quality Assurance Engineer

Sr. Design Quality Assurance Engineer

Department: Quality

Employment Type: Full Time

Location: Burlington, MA

Description

Why should you join our success story?

Based on patented technology developed at MIT, Harvard Medical School and by the Company, Myomo develops and markets the MyoPro product line of lightweight, non-invasive, powered arm braces (orthoses) to restore function in paralyzed or weakened arms and hands of individuals that have suffered a stroke, spinal cord, or nerve injury. (E.g. brachial plexus injury or other neuro-muscular disabilities.) It is the only device that, sensing a patient's own neurological signals through non-invasive wearable sensors, can restore the ability to use their arms and hands so that they can live independently, increase their quality of life, reduce cost of care, and return to work. Published clinical research shows a clinically significant instantaneous reduction in upper extremity impairment with the MyoPro. Our technology has been referred by leading-edge rehabilitation facilities including Mayo Clinic, Kennedy Krieger Institute, Cleveland Clinic, Loma Linda Medical Center, Massachusetts General Hospital, numerous VA Hospitals, and more. Myomo is headquartered in Burlington, Massachusetts, with sales and clinical professionals across the U.S.

What we're looking for:

The Sr. Quality Design Assurance Engineer will be a key member of Myomo's Quality organization, supporting the development and introduction of innovative medical devices. As part of the Design Quality team, this individual will thrive in a collaborative and dynamic environment that values teamwork, adaptability, and risk-based decision-making.

The ideal candidate is proactive, self-driven, and capable of making meaningful contributions within a cross-functional team. Strong written and verbal communication skills are essential.

This role will focus on ensuring product quality throughout the new product development (NPD) process, including support for line extensions of existing products and design-related activities. The engineer will play a critical role in delivering high-quality products to our customers and will be responsible for independently planning and executing technical projects and strategic initiatives, with guidance from leadership and key stakeholders.

How you'll drive impact:

• Lead and/or support the design and development of medical devices in collaboration with R&D and external partners, including contributions to software requirements and electrical/software architecture planning.
• Lead and/or participate in risk management activities, including the development and execution of Failure Modes and Effects Analyses (FMEA) and Hazard Analyses (HA).
• Apply advanced risk management methodologies and mitigation strategies, demonstrating proficiency with industry-standard tools and best practices.
• Utilize statistical analysis and design/process excellence tools to develop robust test plans and evaluate test data and manufacturing processes.
• Demonstrate strong expertise in Design and Process Verification & Validation, including Gauge R&R studies and statistical sampling plans.
• Support the development and execution of test methods for equipment, process, and product qualifications and validations.
• Provide support for design transfer to manufacturing, ensuring a smooth transition from development to production.
• Drive and contribute to root cause investigations using structured problem-solving methodologies; evaluate and verify the effectiveness of corrective and preventive actions.
• Provide quality leadership across all aspects of the Quality Management System, including but not limited to CAPA, Risk Management, Complaints, Post-Market Surveillance, and Nonconforming Material processes.
• Ensure full compliance with design control requirements, including software specifications, detailed design documentation, design verification and validation, risk management, and complete and accurate Design History File (DHF) content, aligned with internal procedures and applicable FDA and ISO standards.
• Participate in and support Design and Technical Review activities throughout the product lifecycle.
• Communicate effectively across all levels of the Quality organization and cross-functionally with teams such as R&D, Regulatory Affairs, Marketing, and Manufacturing.
• Exhibit strong project management and leadership capabilities, driving quality-focused initiatives and cross-functional alignment.

What you'll bring:

• Bachelor's degree in Engineering (Biomedical, Mechanical, Electrical, Systems) or a related technical discipline required; minimum of 5 years of relevant experience in the field. Master's or other advanced degree is a plus.
• Demonstrated excellence in problem-solving, decision-making, and root cause analysis.
• Strong interpersonal skills with the ability to resolve conflicts in technical settings.
• Prior experience in the medical device or healthcare industry is required.
• In-depth knowledge of regulatory and quality standards, including Design Controls, GMPs, QSR (21 CFR 820), ISO 13485, IEC 62366, EU MDD/MDR, and ISO 14971.
• Proven expertise in Quality Engineering with a successful track record in design optimization, verification, validation, and Failure Modes and Effects Analysis.
• Solid understanding and application of statistical tools and methodologies in new product development.
• Familiarity with hardware, software and mechanical product design is preferred.
• Experience in both product development and manufacturing environments is preferred.
• Demonstrated ability to implement continuous improvement initiatives in Design Controls and Engineering Practices to drive business results.