Process Engineer - Micro Tech
Watertown, MA
About the Job
120-130K
Minimum 7 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.
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.