Manufacturing Sr Engineer II

Full-time - Mid Level

Norfolk, VA

Miscellaneous Manufacturing

About the position

The Manufacturing Sr. Engineer II is responsible to drive process improvement and process optimization, equipment lifecycle management, and regulatory compliance, ensuring high production efficiency, quality, and cost-effectiveness. This role is integral in leading process validation, equipment qualification, and continuous improvement initiatives while upholding safety standards. The ideal candidate will collaborate cross-functionally with Operations, Quality, R&D and Supply Chain to implement best practices and cutting-edge manufacturing technologies.

Responsibilities

• Develop, maintain and improve controlled technical documentation (prints, procedures, work instructions, specifications, acceptance tests, commissioning plans, transfer documents, and master plans)
• Deep understanding of manufacturing processes used in medical device production and supporting a wide variety of processing applications such as biomaterial transformations and packaging
• Analyze and improve existing manufacturing processes to enhance efficiency, yield, and cost savings
• Implement lean manufacturing and Six Sigma methodologies to reduce waste and variability
• Collaborate with Product Development teams to transition new products from design to full-scale production
• Lead and manage complex projects with high-impact deliverables, ensuring timely execution
• Lead equipment qualification or process validation projects to maintain compliance and operational excellence
• Identify and resolve complex product and process performance issues
• Hands on approach to selection, installation, troubleshooting, diagnostic and repair of manufacturing equipment
• Design, develop, and implement new manufacturing equipment, fixtures, and tools to enhance production capabilities
• Ensure compliance with ISO 13485, FDA 21 CFR Part 810, GMP and EU MDR standards

Requirements

• B.S. in Engineering required
• 5-7 years of manufacturing engineering experience in a regulated industry (pharmaceutical, biotech, medical device, aerospace, automotive, etc.) preferred
• Sound understanding of concepts and principles for manufacturing and new product processing
• Full working knowledge of all supporting department needs and capabilities
• Extensive knowledge of mechanisms required to implement processes and manage product flow
• Full working knowledge of the development process and procedures
• Competence with drafting standards and geometric dimensioning and tolerancing
• Ability to balance marketing, manufacturing, and design requirements to meet customer requirements
• Ability to lead and prioritize complex projects assignments and complete work in a timely manner
• Good problem-solving skills through the use of quality and statistical tools
• Ability to effectively work and communicate within a cross-functional team
• Demonstrates good written and verbal communication skills
• Microsoft Office Suite and Project proficiency
• Minitab knowledge is preferred
• Expertise in equipment qualification, process validation, and risk management
• Experience with CAD software, PLM systems, and engineering tools
• Ability to manage multiple priorities in a fast-paced, dynamic environment
• Strong analytical and problem-solving skills, including root cause analysis, data analysis, statistical methods, FMEA, and CAPA investigations
• Working knowledge of ERP/MRP systems to support production planning and efficiency

Nice-to-haves

• Knowledge in Lean Principles and or Six Sigma or other problem-solving methodology is preferred
• Knowledge on how to conduct investigations and root cause analysis is preferred

Benefits

• Development opportunities
• Robust employee resource groups (ERGs)
• Flexible working environment
• Location specific competitive total rewards
• Wellness incentives
• Culture of recognition and performance awards