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SalaryLocation: Onsite Southwest of Boston
JOB DESCRIPTION:
We are seeking a highly motivated, very hands-on, and skilled Process Engineer to join our dynamic team, who has extensive experience in providing technical support and driving improvements in day-to-day manufacturing. This Process Engineer will be the technical subject matter expert, who owns the manufacturing processes for our automated coating value stream, monitors all processes, and leads continuous improvement. As Process Engineer, you will play a crucial role in ensuring we deliver best in class service for quality, on-time delivery, and overall customer satisfaction.
RESPONSIBILITIES:
- Collaborates with scheduling and manufacturing team on day-to-day production needs (includes updating headcount staffing models, performance measurement boards, machine capacities, material replenishment plans, production scheduling, machine maintenance scheduling).
- Troubleshoots and resolves manufacturing issues, involves maintenance and equipment engineer as required.
- Establishes and maintains robust process controls and monitoring plus quality and safety standards to ensure products meet or exceed customer requirements.
- Maintains Value Stream Maps and updates takt time for their value streams.
- Leads kaizen and process mapping activities for the value streams.
- Completes engineering studies to characterize and optimize manufacturing processes.
- Manages continuous improvement project portfolio for our coating value streams.
- Drives process changes and technology integration strategies to scale manufacturing operations to meet future growth.
- Owns the manufacturing technology roadmaps.
- Establishes and maintains current and future state (3P) value stream layouts.
- Develops operator on the job training and updates work instructions.
- Provides technical training to operators, process technicians, and engineering team as needed.
- Performs scrap tracking and manages scrap reduction initiatives.
- Develops key process metrics and controls and can utilize an MRP system as needed.
- Performs other related duties as assigned by management.
The individual must possess the following knowledge, skills and abilities and be able to explain and demonstrate that he or she can perform the essential functions of the job, with or without reasonable accommodation.
- Minimum 10 years of Process Engineering experience, preferably in the medical device industry.
- Proficient knowledge and application of GMPs ISO 13485 system requirements, and knowledge of equipment qualifications tools (i.e., IQ, OQ, PQ).
- Must be customer focused, have a strong quality mindset, and make effective risk-based decisions.
- Able to successfully manage complex projects and has experience in driving continuous improvement projects and strategies.
- Possesses practical experience Lean and Six Sigma; certifications are a plus.
- Must be able to work in a fast-paced cross-functional team environment, with minimal supervision, and effectively communicate and present to all levels of an organization.
- Possesses excellent interpersonal skills along with strong analytical, change management, critical thinking, attention to detail, influencing, and problem-solving skills.
- Able to perform technical writing, develop training, quality procedures, databases, and dashboards.
- Demonstrates good financial and business acumen, able to manage capital projects.
- BS or advance degree in Engineering is preferred.
