Process Development Associate Engineer

Company Overview

Biomerics is a world-class manufacturer and innovative polymer solutions provider for the medical device and biotech industries. As a vertically integrated company, we specialize in designing, developing, and producing medical devices for diagnostic and interventional procedures. We are focused on next-generation solutions for vascular access, electrophysiology, cardiac rhythm management, neurovascular, structural heart, and cardiovascular markets.

At Biomerics, we are dedicated to our diverse employee base. We understand that a strong, skilled, and engaged workforce is the foundation of our continued success as a business. We strive to live up to the Biomerics values in all our interactions. It is an exciting time to be part of our collective team, and there is no limit to the impact that can be achieved here at Biomerics. We improve and advance our employees' lives and the lives of the patients who depend on our products.

At Biomerics, we are guided by our core values of integrity, partnership, empowerment & accountability, trust, agility, teamwork, and excellence. We deeply care about our team members and customers, and our team-oriented, customer-focused corporate culture places a premium on building strategic, mutually beneficial partnerships. Joining our team means becoming part of a dynamic, innovative, and caring community.

POSITION SUMMARY:

Experience in the development of machined components using Swiss-type CNC lathes, including machine setups and programming in ESPRIT. Experience with validation processes within the medical device industry (PD, IQ, OQ, PQ).

KEY FUNCTIONS

Program, validate, train personnel, and document CNC processes to ensure accuracy, stability, and regulatory compliance in the production of critical medical device components.

ADDITIONAL RESPONSIBILITIES:

• Create and optimize CNC programs, defining cutting parameters, tooling, and machining sequences.
• Develop QPs (Quality Plans) and generate detailed MPIs (Manufacturing Process Instructions).
• Create and maintain the BOM (Bill of Materials), including the required components and tooling.
• Coordinate TMVs (Test Method Validations) and FAIs (First Article Inspections).
• Identify and control CTQs (Critical to Quality) product characteristics.
• Develop MVPs (Master Validation Plans) for new projects.
• Prepare documentation related to process and product validation.
• Ensure compliance with ISO 13485, FDA regulations, and internal standards.
• Collaborate with Process Engineering, Quality, and Production teams to resolve technical issues and optimize manufacturing time.

EDUCATION AND EXPERIENCE:

• CNC Specialist Technician and/or university degree in Mechanical Engineering, Electromechanical Engineering, or a related field.
• Bilingual English-Spanish proficiency (B2).
• Minimum of 2 years of experience in CNC programming and high-precision metalworking processes within the medical device industry.

KNOWLEDGE, SKILLS, AND COMPETENCIES:

• CNC programming experience with Fanuc, Citizen, Star, Tsugami, Willemin, and other CNC systems.
• Knowledge of high-precision metalworking processes.
• Experience with IQ/OQ/PQ validations and quality tools such as FMEA and SPC.
• Knowledge of ISO 13485 standards and Lean/Six Sigma methodologies.
• Strong interpersonal and teamwork skills.
• Critical thinking, results-oriented mindset, and commitment to continuous improvement.