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Sr. Process Engineer
Greater Boston
Our team in Boston MA is searching for a Sr. Process Engineer II to join their team. This position leads initiatives for the daily support of products, processes, materials, and equipment to meet production area goals. In our start up, fast-paced and dynamic environment, this person will be responsible for setup and enhancement of several manufacturing processes both at AVS and our suppliers while working cross-functionally with R&D, Quality, Process Development, and Production teams to achieve goals.
Your Responsibilities Will Include
Set up and monitoring the performance of equipment, machines and tools
Correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues
Communicate effectively to an audience consisting of peers and management
Organize and prioritize own daily work routine to meet production requirements and project schedules
Troubleshoot new and existing products/process problems as related to design, material, or processes
Apply problem solving and process improvement methodologies to improve complex and diverse manufacturing processes, ensuring root cause of problem is identified and quickly resolved.
Support in the training of team members on specific tasks, including other engineers, technicians, and product builders
Recognize quality signals and escalate appropriately, using quality system tools
Incorporate business policies and procedures into task completion
Lead and/or participate in project-focused work and teams
Work under general direction to identify, implement, and manage equipment requirements to support production goals
Work with vendor/suppliers to design, procure, and fabricate equipment tooling and fixtures
Leverage existing and emerging technologies to meet business needs
Design and coordinate standard engineering tests and experiments
Consistently summarize, analyze, and draw conclusions from test results
Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, and Supply Chain
Required Qualifications
Bachelor’s Degree in engineering; preferably Mechanical or similar discipline
8+ years experience in a rapidly evolving process development and manufacturing environment
Understanding of engineering principles theories, concepts, practices, and techniques
Ability to manage multiple projects and responsibilities simultaneously
Ability to effectively develop, validate, improve manufacturing processes,
Proficient in Microsoft Office Suite
Preferred Qualifications
Prior experience in a regulated medical device manufacturing, including catheters and electro mechanical devices
Demonstrated hands on knowledge working with internal and external suppliers
Experience leading scale up for commercial activities.
Experience with Minitab or other statistical software
Equipment and process validation experience
Highly collaborative, with strong written and verbal communication skills