Design Quality Assurance Engineer

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: 

The Design Quality Assurance Engineer will be expected to apply knowledge of design controls, human factors, risk management and quality engineering techniques to the development process of medical devices, as a member of one or more cross-functional teams. This role is responsible to ensure that products are developed in accordance with applicable regulatory requirements, customer expectations, industry standards and successfully transferred to manufacturing.

Main responsibilities:

• Apply company policy and procedures
• Supports the design controls process during development of new medical devices or design changes including: Planning, Design requirements, Design Validation and Verifications, and Design transfer specifications.
• Support Design related root cause and corrective action investigations
• Lead the Usability Engineering activities including: Usability strategy plan, Usability strategy report, Formative and Summative Evaluations.  
• Review and approve Engineering documentation, such as: Design controls deliverables, CAPAs, NCs, CCPs, etc.
• Coordinates the creation, review and updates of Risk Management Files and Reports for all applicable product families along with the Ops Quality and the Quality System departments.
• Other functions may be assigned by management based on his/her knowledge and experience. 

Requirements:

• Bachelor´s degree in Industrial Engineer, Industrial Production Engineer, Biomedical Engineer, Mechanic Engineer, Chemical Engineer, Material Engineer
• 2 years of Experience in Medical Industry within Quality Department
• Intermediate English (written & spoken)
• Team player
• Strong communication skills
• Analytical thinking

Assessment Center:

Please note the recruitment process for this role includes: initial interview, assessment center evaluation, hiring manager interview.

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.