RDI Sustaining Engineer

San José , Costa Rica
full-time

AI overview

Ensure product design activities align with regulatory requirements and quality standards while driving continuous product improvement in a hyper-growth healthcare company.

About Us:


Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing an innovative portfolio of advanced medical aesthetic device technologies and wellness solutions. It is currently the world’s fastest-growing women’s health company.


Our Femtech solutions are proudly produced at two MDSAP-certified, carbon neutral, LEED Gold certified, state-of-the-art manufacturing facilities in Costa Rica and are approved for sale in more than 85 countries.

Since 2018 the company trades on the NASDAQ stock exchange under the ticker symbol ESTA and has a market cap of around $1.8 billion.


This is an exciting opportunity to join an innovative international company in hyper-growth as we launch a significant revolution to transform the women´s aesthetics industry. 


Objective:

To ensure that all product design activities align with regulatory requirements, quality standards, and business objectives—driving continuous product improvement while maintaining compliance and ensuring that the company’s products remain state-of-the-art, safe, and competitive in the market.


Main responsibilities:

  • Provide technical support on product’s design for regulatory registrations/submissions
  • Maintain updated any change or modification in product dossiers/technical documentation
  • Monitor and assess the performance of marketed products 
  • Lead changes to improve current products
  • Active participation in quality system support related with corrective and preventive actions associated with product’s design. 
  • Control indicators/progress the strategic projects.


Requirements:

  • Bachelor´s degree in Industrial Engineering, Chemical Engineering or other STEM related area 
  • Minimum 2 years of experience in medical Industry or related areas. 
  • Advanced English (B2+ or higher), both written & spoken.
  • Proficiency in Office package, Minitab.
  • Flexibility
  • Adaptability
  • Stakeholders management
  • Client management
  • Collaborative thinking
  • Problem-solving skills


Important Note: This job description includes the necessary aspects required to evaluate this job position. It should not be used as a comprehensive list of all responsibilities, skills or functions.


At Establishment Labs we’re committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability (visible and not visible), gender, gender identity or expression, or veteran status. We strive to be a more equal opportunity workplace.

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