|Title:||Manufacturing Process Engineer|
Working under the guidance of the Operations Manager, the Manufacturing Process Engineer executes numerous functions within an ISO 13485 registered Quality Management System. In this role, you must be detail oriented for QA activities involving a variety of different products, assemblies, and components using various manufacturing and assembly processes as related to a medical device contract manufacturing company. The individual must have flexibility to change assignments on short notice in order to accommodate the changing priorities of a fast-paced manufacturing environment. Independent judgment is required to plan, prioritize and organize a diversified workload, resolve problems, effect changes to manufacturing processes or procedures, and react in a positive manner to internal and external customer demands.
If this sounds like you, please consider joining our team!
Essential Job Responsibilities include:
- Ability to work within an ISO 13485 or 9001 Quality Management System environment;
- Execute Engineering Change Notices from customers and internal sources
- Write and execute Validations (Sterilization, Sealing, Packaging/Aging);
- Perform advanced quality planning functions, including Gage R&R & MSA, drawing reviews, capability studies, production documentation approval, inspection plans;
- Material Review Board and NCMR disposition activities and processing;
- Corrective Action & Preventive Action execution and system maintenance;
- Customer complaints;
- Statistical Analysis, including SPC, ANOVA, T-Test, F-Test, capability studies;
- Lead pFMEA sessions and lend support for dFMEA meetings;
- Author Level 2 and Level 3 SOPs and Work Instructions;
- Train team members on new system processes, SOPs, Work Instructions, measurement techniques, and general Quality Management System requirements;
- Day-to-day support for production issues;
- Clear, neat, and precise documentation of all activities for presentation to management, customers, suppliers, Material Review Board, and history files;
- Accurate transcription of part numbers, lot numbers, and general reporting of activity results
- Inspection of product using standard inspection plans and gages such as micrometers and vernier/calipers, optical comparators, and visual coordinate measurement systems;
- Testing of product using tensile testing equipment;
- QMS documentation review and management (Device Master Records, Device History Records, CAPA and Complaint system);
- Improve productivity performance by reducing waste and improving the processing for units.
- Improve quality performance by identifying and eliminating the variation in the process.
- Provide technical support for packaging equipment used in various processes.
- Maintain/design equipment maintenance procedures for all equipment used in manufacturing processes.
- Maintain/ design all work instruction/ travelers used throughout manufacturing processes.
- Provide technical support regarding all safety and ergonomics issues within the area.
- Work closely with Supervisors, Team Leads and Quality in order to meet customer expectations.
- Design (using SolidWorks) and procure tooling/fixtures to support the assembly and test processes in manufacturing.
- Maintain good working relationship with customers. Keep customers informed of quality problems and solutions as necessary.
- Lead the introduction of new products into Operations.
- Lead continuous improvement teams focused productivity increases / waste reduction and first pass yield improvements.
• 1-5 years manufacturing engineering experience within a manufacturing environment leading and participating in complex projects.
• Bachelor’s Degree in Manufacturing, Industrial Technology or related area of study.
• Experience using SolidWorks
• Experience/ knowledge with GMP, DEP,FDA and ISO13485
• An understanding and previous use of continuous improvement tools.
• Ability to perform multiple tasks in a fast-paced environment.
• Good interpersonal skills with ability to deal with all levels in the organization while remaining customer oriented.
• Applies proven technology independently.
• Medical device manufacturing experience preferred