Sr. Quality Engineer

5 days ago

Marlborough MA United States Michael Page Full time

The Design Quality Engineer will play a critical role in ensuring that medical devices meet regulatory and quality standards throughout the product development lifecycle. This position involves collaborating with cross-functional teams to identify design risks, implement process improvements, and maintain compliance with ISO and FDA regulations.

Client Details

My client is a leading innovator in the field of electrophysiology, specializing in advanced solutions for the treatment of atrial fibrillation (AFib). Their state-of-the-art technologies, including laser-based and pulsed-field ablation (PFA) systems, are designed to improve the precision, efficiency, and outcomes of cardiac arrhythmia treatments. With a strong focus on research and development, they provide cutting-edge tools that enable physicians to perform ablations with greater accuracy, reduce procedure times, and enhance patient care.

Their flagship products, incorporate advanced energy delivery and visualization techniques, making them unique in the electrophysiology space. These systems seamlessly integrate into existing clinical workflows, supporting electrophysiologists in treating complex cardiac conditions with confidence. The company is committed to advancing the treatment of AFib through innovation, providing both physicians and patients with effective solutions that drive better clinical results and improve quality of life

Description

  • Lead Design Assurance activities throughout the product life cycle
  • Provide expertise in Risk Management, Design Verification, and Validation (DV & V)
  • Oversee Test Method Validation (TMV) and Process Validation (PV) activities
  • Apply statistical methods to support product development and testing
  • Utilize systematic problem-solving to address and resolve quality issues
  • Stay current with regulatory requirements and standards for medical device development
  • Guide and mentor engineering team members in Design Control processes
  • Support complaint handling and Corrective and Preventive Actions (CAPA) as needed
  • Ensure compliance with design controls throughout the product life cycle
  • Contribute to the development and execution of validation plans
  • Review and approve relevant documentation for design assurance activities
  • Perform additional responsibilities as assigned by leadership

Profile

  • BS in science or engineering with 5+ years of experience in quality management within the medical device or life sciences industry - experience as a Design Quality Engineer at a medical device manufacturer preferred
  • Background in electrical engineering preferred, with experience in Class III medical devices and cardiac electrophysiology devices a plus
  • Demonstrated leadership skills and the ability to manage teams to meet company objectives
  • Strong problem-solving abilities, able to collect and organize diverse information to guide decisions and ensure product quality
  • Experience in prioritizing and planning work, setting goals, and managing tasks for self and others
  • Excellent written and verbal communication skills, with the ability to interact effectively across all organizational levels
  • Deep knowledge of quality engineering principles, medical device requirements, and regulatory standards
  • Ability to train and mentor others on quality engineering concepts and medical device compliance
  • Familiarity with US FDA regulations, ISO standards, and applicable industry guidelines
  • Experience in managing and improving quality systems and ensuring product compliance
  • Strong organizational and planning skills to manage multiple projects concurrently
  • Ability to identify and address gaps in quality processes to ensure continuous improvement

Job Offer

  • Medical Benefits: Great options available, allowing employees to select plans that best meet their needs.
  • Dynamic Work Environment: Fast-paced and exciting atmosphere with a growing company.
  • Career Growth: Opportunities to take on various roles and projects, gaining valuable experience.
  • Recognition: Superiors value and appreciate employee contributions, providing a gratifying work experience.
  • Company Culture: A supportive and positive work environment that fosters teamwork and individual success.
  • Long-Term Outlook: Room for growth within the company, though potential future changes are a consideration.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

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