Quality Engineer Intern

Lexington Medical is a medical device manufacturer in the Boston area that produces minimally invasive surgical stapling solutions. Our unique customer-centric approach to engineering has allowed us to be agile and responsive to the stapling market and has yielded 3x revenue growth in the last two years. Our business structure enables us to produce a unique range of devices and proprietary technology best suited for leading surgeons and their patients, while also quickly adapting to the everchanging market conditions.

Our recruiting philosophy is centered on attracting talented individuals committed to delivering innovation. Rooted in a talent dense culture that fosters continuous growth and achievement, both personal and organizationally, we've been organically scaling at a rapid pace and have aggressive hiring plans for the years ahead. By joining Lexington Medical, you will have the opportunity to impact the lives of millions of patients worldwide and thrive in a growing company.

Program Overview: Lexington’s Summer Intern Program is intended to attract undergraduate and graduate college students who are studying Biomedical Engineering, Mechanical Engineering or other related fields. You will be given the opportunity to meaningfully contribute to the progress of Lexington and its products, while gaining business acumen and real-world experience which will better prepare you to continue to make impactful contributions throughout your career.

Education: Must be a rising Junior or above attending an accredited university majoring in Biomedical Engineering, Mechanical Engineering, or a similar technical discipline

Location: Bedford, Massachusetts

Responsibilities:

• Participate in Design Assurance activities throughout the Product Life Cycle.
• Provide support in Risk Management, Design Verification and Validation, Statistical Methods, and Design Controls.
• Drive quality system execution to US and international standards, including the development of quality and risk management plans.
• Support regulatory submissions and Technical Documentation.
• Assist in continuous improvement and CAPA projects.
• Develop test methods and inspection procedures and implement process control systems to support the development, qualification, and ongoing manufacturing of products.
• Support supplier quality management, including conducting sub-contractors and component supplier audits.
• Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues.
• Support Post-Market Surveillance (PMS) activities, including complaint handling and investigation, root cause analysis, and vigilance reporting.
• Be a champion for Quality and support quality disciplines, decisions, and practices.