Principal Manufacturing Engineer

Principal Manufacturing Engineer

Requirements

• Requires a Baccalaureate degree and minimum 7 years of relevant experience, or advanced degree with a minimum of 5 years of relevant experience.

Responsibilities

• Support technical recruitments, trains, and mentor all Needles Manufacturing Engineering personnel.
• Develop and implement policies, standards and procedures for the engineering and technical work performed in the department, including storing of equipment documentation, spare computer components, and system backups.
• Apply knowledge of manufacturing processes, machine design, and components to provide technical direction for staff to troubleshoot, maintain, and modify automated and manual equipment.
• Improve and manage process tooling, drawings, custom design fixtures and machine modifications.
• Contribute to continuous improvements in overall product cost and quality.
• Advise leadership of developments which may affect profit, schedule and costs.
• Lead on projects to concurrently develop assembly methods, tooling, equipment and processes for new and existing products.
• Partner with Manufacturing to develop lean principals to implement solutions for product manufacturing.
• Create standardized work charts, work combination tables and process maps that result in an optimized production system and extended value stream.
• Support project team members in achieving business including attainment of Safety, Quality, Service, and Project Schedule and Cost goals.
• Follow established procedures to perform detailed, accurate, and compliant engineering documentation for Master Validation Plans, PFMEA, Equipment Installation, Characterization, Qualification and Validation activities.
• Daily interaction with manufacturing providing support and responsibility for metrics such as labor time, lead-time, capability, and yield.
• Provide detailed engineering analysis and documentation in the management of material disposition, process updates, NCR’s and CAPA.
• Complete on time project updates, development plans, self-assessments, and successful completion of all training requirements.
• Use of Project Management tools including Gantt charts, risk matrix’s, project charters are required.
• Review existing equipment for opportunities to address EHS and ergonomics concerns, address non-conformances, improve product quality, improve OEE, and improve throughput.
• Collaborating with other site principal engineers to share knowledge and follow best practices.
• Organizes the coordination of activities with equipment vendors and consultants to ensure timely delivery.
• Communicate and coordinate activities with multiple functional groups both within and outside of operations.
• Up to 10% travel required.

Preferred Qualifications

• 7+ years of experience with developing technical solutions to solve complex problem.
• Experience in validation (IQ/OQ/MSA/PQ) in a medical device environment.
• Experience in manual and automated assembly equipment.
• Dynamic, positive attitude.
• Strong communication, manufacturing process, product industrialization and leadership skills.
• Solid troubleshooting and presentation skills.
• Knowledge of Lean and/or 6 Sigma.
• Knowledge of GD&T.
• Knowledge of DFMEA and PFMEA.
• Knowledge of Maintenance Uptime Elements.
• Practical Knowledge of Maintenance SOP’s in a regulated environment, (FDA 21 CFR Part 820 or similar)