Engineer I, Product Processing & Digital Engineering

Support manufacturing process development and manufacturing of products for medical devices with work including creation and maintenance of digital product processes; testing enterprise systems and business processes. Work closely with Operations, R&D, Quality, Regulatory and IT in supporting the development of new products and manufacturing processes to achieve smooth, successful transfers to Production for launch. Job duties:

• Improve, sustain, develop, and support new and existing manufacturing processes for new and existing products, product changes, and enhancements.
• Support validation of enterprise system and business processes.
• Interface with other departments to solve product data and process issues.
• Investigate and test product processes in data systems.
• Support data management for Pilot Production, Facilities, and Planning.
• Draft and execute validation of product and process systems and data.
• Support organizational training in the areas of enterprise systems usage and data-related business processes.
• Analyze data and improve processes to ensure robust/repeatable data management processes.
• Review and develop manufacturing documents (e.g., Work Instructions, Build Records, BOMs, etc.).
• Comply with applicable Laws and Regulations, adhere to Quality Management System processes and requirements as well as demonstrate Ethics and Integrity in all matters and at all levels throughout the organization.
• Perform additional duties as assigned.

1. Bachelor of Science in Mechanical, Manufacturing, or Industrial Engineering, or a related field of study.
2. Zero (0) to two (2) years of related experience.
3. Strong written and verbal communication skills.
4. Computer skills including Word, Excel, PowerPoint, Outlook, and Teams.
5. Ability to read and prepare technical documentation.

Desired Qualifications

1. Knowledge of enterprise data management systems.
2. Good problem solving and conflict management skills.
3. Knowledge of medical and technical development.
4. Proficiency in SolidWorks (and/or CAD).