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Full-Time

V&V Engineer

Posted on 10/23/2024

Lexington Medical

Lexington Medical

51-200 employees

Develops advanced surgical stapling technology

Industrial & Manufacturing
Healthcare

Junior, Mid

Bedford, MA, USA

This position is onsite in Bedford, MA.

Category
QA & Testing
Quality Assurance
Required Skills
SolidWorks
Requirements
  • Bachelor’s degree in mechanical engineering or comparable engineering field.
  • 2+ years of experience in V&V, quality, and/or testing engineering roles with electro-mechanical systems in a highly regulated industry such as medical device, defense, or automotive. Internship/ co-op experience is included.
  • Experience working with a Quality Management System.
  • Ability to communicate technical findings with a cross-functional audience and stakeholders.
  • Proficiency in SolidWorks or comparable solid modeling software.
  • Proven ability to work in a fast-paced, dynamic environment.
  • Curiosity and excitement to learn new processes, strategies, and methods.
Responsibilities
  • Develop high-level verification and validation testing plans for electromechanical systems in collaboration with mechanical, electrical, and software engineers.
  • Translate functional design requirements and user needs into appropriate success criteria for test cases and methods.
  • Create and take ownership of testing protocols and reports throughout the development and product lifecycles.
  • Support the creation and execution of early concept testing.
  • Synthesize testing results and distill learnings into actionable product improvements in cooperation with design engineers.
  • Own product testing timelines and work with product managers to ensure on-time completion of project deliverables.
  • Perform investigations and root cause analysis of complex electromechanical problems.
  • Design, build, and document custom testing fixtures to improve existing and new testing procedures.
  • Identify areas for improvement in testing procedures, fixtures, and methods.
  • Train testing technicians.

Lexington Medical focuses on surgical stapling technology for hospitals and surgical centers, particularly in bariatric and gastrointestinal surgeries. Their advanced stapling systems aim to improve clinical outcomes by reducing complications and shortening hospital stays. The company operates a vertically integrated model, ensuring high quality through control of product development and manufacturing. Lexington Medical's goal is to enhance surgical procedures and become a trusted partner for surgeons worldwide.

Company Stage

Seed

Total Funding

$6.6M

Headquarters

Billerica, Massachusetts

Founded

2013

Growth & Insights
Headcount

6 month growth

0%

1 year growth

0%

2 year growth

0%
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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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