Design Quality Engineer

Methuen, Massachusetts Permanent USD115,000 - USD140,000 per year
  • Innovation & Impact on Healthcare
  • Professional Growth and Learning Opportunities

About Our Client

My client is a renowned and innovative medical technology company that has garnered widespread acclaim for its groundbreaking contributions to organ transplantation. The company's flagship product stands as a testament to its commitment to pushing the boundaries of medical science. My client has revolutionized organ preservation by allowing for real-time monitoring and optimization, significantly improving transplant outcomes.

One of my clients' strengths lies in its dedication to quality, with a focus on adhering to stringent regulatory standards such as ISO 13485 and FDA requirements. The company fosters a dynamic work environment that encourages continuous learning and professional growth, making it an attractive destination for individuals passionate about making a positive impact on healthcare. The collaborative culture at my clients facility, coupled with effective communication channels, ensures that employees work seamlessly across cross-functional teams.

My client has played a pivotal role in advancing the field of transplant medicine, enhancing the success rates of life-saving procedures and ultimately improving patient outcomes. Their commitment to innovation, coupled with a mission-driven approach, positions my client as a leader in the quest to address critical challenges in organ transplantation. Overall, my client stands as a beacon of excellence in the medical technology sector, driven by a vision to transform and improve the landscape of healthcare through cutting-edge solutions.

Job Description

  • Collaborate with the design team to ensure that medical device designs meet quality and regulatory requirements.
  • Develop and implement quality plans and procedures for design control and verification/validation activities.
  • Conduct risk assessments and analyses to identify potential design issues and mitigate risks.
  • Review and approve design documentation, including specifications, drawings, and test protocols.
  • Lead or participate in design reviews to assess compliance with quality standards and regulatory requirements.
  • Coordinate with cross-functional teams to address design-related issues and drive resolution.
  • Perform root cause analysis and implement corrective and preventive actions for design non-conformities.
  • Maintain awareness of relevant regulatory changes and ensure compliance with FDA regulations and ISO standards.
  • Support design changes and modifications by evaluating their impact on product quality and regulatory compliance.
  • Provide training and guidance to design teams on quality assurance processes and best practices.

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.

The Successful Applicant

  • Educational Background: B.S. Degree (Engineering or Technical)
  • Experience: 4-5 years of experience working within Quality Engineering
  • Class 3 Device Expertise: Proven track record of working with Class 3 medical devices, demonstrating a deep understanding of the heightened regulatory requirements and quality standards associated with these complex and critical healthcare products.
  • ISO 13485 Proficiency: Extensive experience and proficiency in implementing and maintaining ISO 13485 quality management systems, ensuring adherence to international standards in the development and manufacturing of medical devices.
  • Clean Room Experience: Demonstrated hands-on experience in working within clean room environments, showcasing the ability to maintain stringent cleanliness and hygiene standards critical to the production of high-quality medical devices.
  • Extensive experience in medical device design and development, preferably in organ preservation and transplantation.
  • Strong understanding of quality management systems, FDA regulations, and ISO standards applicable to medical devices.
  • Proficiency in risk management methodologies and conducting risk assessments for complex medical devices.
  • Demonstrated ability to lead design control activities, including verification, validation, and design reviews.
  • Excellent analytical and problem-solving skills to identify and resolve design-related issues effectively.
  • Detail-oriented mindset with a focus on ensuring product safety, efficacy, and regulatory compliance.
  • Effective communication and collaboration skills to work with cross-functional teams and stakeholders.
  • Proven track record of implementing corrective and preventive actions to address design non-conformities.
  • Ability to adapt to a fast-paced environment and manage multiple projects simultaneously.
  • Commitment to continuous learning and staying updated on industry trends and regulatory changes in the medical device field.

What's on Offer

  • Competitive Compensation
  • Strong Healthcare & Wellness Benefits
  • Retirement Plans
  • Professional Development
  • 401k Match
Cian Troy
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Job summary

Engineering & Manufacturing
Sub Sector
Quality, Technical
Industrial / Manufacturing
Contract Type
Consultant name
Cian Troy
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