Process Engineer I/II

Role Summary

The Process Engineer I/II will contribute to developing, implementing, and maintaining robust and efficient manufacturing processes for new and existing medical devices and pharmaceutical products. This role works with Manufacturing, Product Development, and Quality teams to ensure processes are validated and controlled according to regulatory requirements, and will drive continuous improvement 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 in GMP/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 individually and in a team environment
• Ability to work independently with minimal supervision
• Knowledge of GMP, GAMP, IEEE, ISA, ASTM specs and batch process control in life sciences
• Working knowledge of SolidWorks and AutoCAD is desirable; 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
• Experience in hands-on environment; experience building and setting up equipment
• Understanding of PLCs is helpful but not required; familiarity with manufacturing automation systems is helpful but not required
• Ability to read standard electrical diagrams and logic schematics

Skills

• Process engineering
• Process validation and qualification
• DFMEA/PFMEA and risk assessment
• Equipment specification and installation
• Data analysis and process optimization
• Regulatory compliance (ISO 13485, 21 CFR Part 820)
• Technical drawing and documentation

Education

• Bachelor’s Degree in Chemical/Bio-Medical Engineering or equivalent

Additional Requirements

• Experience in a GMP environment/medical device industry