Sr. Process Engineer

2 days ago

Boston MA United States MassMEDIC Full time

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:
  1. Set up and monitoring the performance of equipment, machines and tools.
  2. Correct equipment problems or process parameters that produce non-conforming products, low yields or product quality issues.
  3. Communicate effectively to an audience consisting of peers and management.
  4. Organize and prioritize own daily work routine to meet production requirements and project schedules.
  5. Troubleshoot new and existing products/process problems as related to design, material, or processes.
  6. Apply problem solving and process improvement methodologies to improve complex and diverse manufacturing processes, ensuring root cause of problem is identified and quickly resolved.
  7. Support in the training of team members on specific tasks, including other engineers, technicians, and product builders.
  8. Recognize quality signals and escalate appropriately, using quality system tools.
  9. Incorporate business policies and procedures into task completion.
  10. Lead and/or participate in project-focused work and teams.
  11. Work under general direction to identify, implement, and manage equipment requirements to support production goals.
  12. Work with vendor/suppliers to design, procure, and fabricate equipment tooling and fixtures.
  13. Leverage existing and emerging technologies to meet business needs.
  14. Design and coordinate standard engineering tests and experiments.
  15. Consistently summarize, analyze, and draw conclusions from test results.
  16. Work cooperatively with R&D, Process Development, Quality, Production, Regulatory, Equipment Engineering, and Supply Chain.
Required Qualifications:
  1. Bachelor’s Degree in engineering; preferably Mechanical or similar discipline.
  2. 8+ years experience in a rapidly evolving process development and manufacturing environment.
  3. Understanding of engineering principles theories, concepts, practices, and techniques.
  4. Ability to manage multiple projects and responsibilities simultaneously.
  5. Ability to effectively develop, validate, improve manufacturing processes.
  6. Proficient in Microsoft Office Suite.
Preferred Qualifications:
  1. Prior experience in a regulated medical device manufacturing, including catheters and electro mechanical devices.
  2. Demonstrated hands on knowledge working with internal and external suppliers.
  3. Experience leading scale up for commercial activities.
  4. Experience with Minitab or other statistical software.
  5. Equipment and process validation experience.
  6. Highly collaborative, with strong written and verbal communication skills.
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