Full-Time
Quality Engineer
Posted on 11/22/2024
Lexington Medical
51-200 employees
Develops advanced surgical stapling technology
Entry, Junior
Bedford, MA, USA
Position requires onsite presence in Bedford, MA.
- Bachelor's or Master’s degree in Engineering or related field
- 1-2+ years of related experience, that would include work/ internships in quality, test engineering, quality engineering, in the medical device industry (experience with electro-mechanical equipment is a plus)
- Experience developing and implementing processes within quality management systems
- Experience in new product development and introduction (NPD/NPI) is helpful
- Some knowledge and/or capability to learn US and international medical device regulations and standards, including 21 CFR 820, EU 2017/45 (MRD), ISO 13485, ISO 14971, IEC 60601, and IEC 62366
- Demonstrated knowledge of design controls, process validation, risk management, and change control
- Demonstrated application of systematic problem-solving techniques and defect avoidance methodologies
- Contribute to the quality assurance activities throughout the product life cycle in adherence to US FDA, EUMDR, ISO13485, and other global standards
- Drive post-market surveillance efforts to identify potential risks and opportunities for improvement
- Develop and continuously improve complaint handling process and the overall Quality Management System
- Contribute to Risk Management, Design Verification and Validation, Statistical Methods and Design Controls
- Support quality system execution to US and international standards, including development of quality and risk management plans
- Drive continuous improvement projects, and proactively identify and implement best-in-class quality engineering practices
- Apply systematic problem-solving methodologies to identify, prioritize, communicate, and resolve quality issues
Lexington Medical focuses on surgical stapling technology for hospitals and surgical centers, particularly in bariatric and gastrointestinal surgeries. Their advanced stapling systems are designed to improve clinical outcomes by closing wounds and connecting tissues effectively. The company stands out by being vertically integrated, controlling all aspects of product development and manufacturing to ensure high quality. Their goal is to enhance surgical procedures and provide trusted solutions for surgeons worldwide.
Company Stage
Series B
Total Funding
$6.6M
Headquarters
Billerica, Massachusetts
Founded
2013
6 month growth
↑ 3%1 year growth
↑ 3%2 year growth
↑ 3%
Simplify's Take
What believers are saying
- Lexington Medical's products have been clinically proven to reduce complications and shorten hospital stays, offering substantial benefits to both patients and healthcare providers.
- The company's state-of-the-art manufacturing facility in Massachusetts leverages the latest automation technologies, ensuring high-quality production and operational efficiency.
- Significant milestones like FDA clearance enhance the company's credibility and marketability, potentially leading to increased adoption and sales.
What critics are saying
- The highly specialized nature of their products may limit their market to specific types of surgeries, potentially constraining growth opportunities.
- Dependence on FDA approvals and clinical validations can introduce delays and uncertainties in product launches.
What makes Lexington Medical unique
- Lexington Medical's vertical integration ensures unparalleled quality control and rapid innovation cycles, setting them apart from competitors who rely on third-party manufacturers.
- Their focus on advanced stapling systems specifically for bariatric and gastrointestinal surgeries allows them to specialize and excel in these high-demand areas.
- FDA clearance for their Powered Stapling System validates their commitment to quality and innovation, providing a significant competitive edge.
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