Process Engineer I/II

Role Summary

The Process Engineer I/II role is part of the Process Engineering department, and will be responsible for developing, implementing and maintaining robust and efficient manufacturing processes for new and existing medical devices and pharmaceutical products. This role works closely with Manufacturing, Product Development, and Quality teams to ensure processes are validated and controlled according to ISO 13485, FDA and other regulatory requirements. The position will drive continuous improvement projects to enhance product quality, reduce costs and improve manufacturing efficiency.

Responsibilities

• Specify and procure new capital equipment, overseeing installation and qualification protocols
• Design, develop and implement new manufacturing processes, equipment, tooling and fixtures for new product introductions
• Conduct process simulations and analyze data to identify inefficiencies, reduce cycle times and minimize scrap
• Assist in development and execution of process validation protocols to ensure processes consistently meet quality standards
• Support internal and external audits by providing documentation and expertise on manufacturing processes
• Conduct process risk assessments, such as PFMEA, to identify and mitigate potential risks to product quality and patient safety
• Support the transfer of processes and products from development to commercial manufacturing, facilitating successful scale-up
• Prepare engineering drawings, specifications, protocols and reports for internal use and regulatory submissions
• Support all manufacturing systems, current and new

Qualifications

• Bachelor’s Degree in Chemical/Bio-Medical Engineering or equivalent with 2 to 5 years’ experience
• Ability to work on multiple projects simultaneously
• Experience working in a GMP environment/medical device industry and ensure 21 CFR Part 820, ISO 13485 and FDA biologics requirements are met
• Ability to read, write and comprehend English
• Good computing skills including Microsoft Office
• Strong communication, interpersonal, and presentation skills for working with diverse teams and management
• Ability to solve practical problems both individually and in a team environment
• Work independently with minimal supervision
• Knowledge of GMP, GAMP guidelines, IEEE specifications, ISA specifications, ASTM specifications and batch process control in the life science industry
• Working knowledge of SolidWorks and AutoCAD; experience using AutoCAD and/or SolidWorks
• Experience in medical device design and application of test standards
• Ability to read, write functional requirement specifications, follow verbal instructions, interpret technical procedures, and technical writing skills beneficial
• Experience working in a hands-on environment
• Experience building and setting up equipment
• Understanding of PLCs would be helpful but not required
• Familiarity with manufacturing automation systems is helpful but not required
• Ability to read standard electrical diagrams and logic schematics