About Us:
Establishment Labs is changing the medical device, breast health, aesthetics and reconstruction industry by designing, developing, and manufacturing innovative portfolio of advanced medical aesthetic device technologies and wellness solutions.
We are a leading Femtech company with state-of-the-art manufacturing facilities in Costa Rica that are MDSAP-certified, carbon neutral, and LEED Gold certified.
We have been publicly traded on the NASDAQ stock exchange since 2018 under the ticker symbol ESTA and have a significant presence in the market.
This is an exciting opportunity to join a dynamic international company in hyper-growth as we launch a revolution to transform the women's aesthetics industry.
Objective:
We are seeking a highly motivated Process Engineer who can leverage their academic knowledge and practical skills in manufacturing processes to enhance production operations.
The ideal candidate will be committed to optimizing manufacturing efficiency, ensuring regulatory compliance, and driving continuous improvement initiatives within a collaborative team environment.
Main Responsibilities:
1. Support the design and development of manufacturing processes.
2. Participate in process validation activities and ensure compliance with regulatory standards (e.g., FDA, ISO).
3. Collaborate with cross-functional teams to resolve complex issues and optimize manufacturing efficiency.
4. Spearhead the implementation of lean manufacturing principles and advanced process optimization strategies.
5. Oversee the documentation and standardization of manufacturing procedures and specifications.
6. Lead the documentation of Nonconformities and CAPAs.
Job Requirements:
7. Bachelor's degree in Engineering or related field (e.g., Mechanical, Industrial, Biomedical).
8. 2 years of experience in similar roles within the medical industry.
9. Knowledge of Six Sigma Methodology (green belt certification is preferred).
10. Proficiency with programs such as Excel, MiniTab, Microsoft Word, Power Point, etc.
11. Intermediate English (writing and reading).