Senior Quality Engineer for Medical Device Development

1 week ago


Bedford, Massachusetts, United States Michael Page Full time

Establish a career in medical device development with a challenging role as Senior Quality Engineer. This position offers an exciting opportunity to lead quality assurance activities throughout the product development lifecycle, focusing on new product development for complex medical devices.

As a member of our team at Michael Page, you will have the chance to work with a cutting-edge organization that is transforming the diagnosis and treatment of complex heart rhythm disorders. With a strong emphasis on collaboration across engineering teams, you will ensure high-quality, patient-specific solutions at our Bedford, MA facility.

We are seeking a highly skilled Senior Quality Engineer with a minimum of 8 years of experience in Quality Engineering. Your expertise in new product development within Class II or more complex medical devices will be essential in driving the success of our products. Additionally, your ability to collaborate cross-functionally with engineering and quality teams will be crucial in achieving our goals.

This role offers a competitive base salary ranging from $140,000 to $175,000, with additional bonus potential of up to 10%. You will also have the opportunity to participate in equity participation through stock options, aligning your personal success with the company's growth. Furthermore, our comprehensive benefits package covers standard health, dental, and vision plans, providing you with peace of mind and financial security.

The ideal candidate will have a strong understanding of FDA regulations and ISO 13485 standards, with a focus on product commercialization readiness. They will be able to work effectively in a hybrid capacity, with up to two days of remote work per week, and be local to Bedford, MA.

  • Responsibilities:
  • Represent Quality Engineering in all phases of design activity, including development, verification, validation, transfer, and design reviews for new product development.
  • Participate in risk management processes, including analysis and documentation throughout product development.
  • Provide quality support to design teams for software, data science, and hardware/systems, ensuring compliance with design control processes and the Software Development Life Cycle (SDLC).
  • Support operational quality activities such as material control, process development, inspection, nonconforming material handling, and supplier management.
  • Conduct inspections and testing of materials, equipment, processes, and products to meet quality specifications.
  • Develop and implement quality system processes to maintain compliance with regulatory and industry standards.
  • Lead cross-functional training on quality and compliance best practices while mentoring QA team members.
  • Manage internal audit activities and readiness for external ISO 13485 certification audits.
  • Expand and maintain knowledge of applicable standards to ensure scalable compliance for product commercialization.
  • Collaborate with sustaining engineering teams on continuous improvement initiatives and equipment qualifications.
  • Be onsite at our Bedford, MA facility at least 3 times per week


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