Process Automation Equipment Engineer

Reports to Vice President, Operations

Role Summary

Reporting to the Vice President of Operations, the Process Automation & Equipment Engineer will design and develop new approaches to optimize process efficiency and improve product quality for a diagnostic catheter-based device. Working with internal R&D and Operations resources and external partners as appropriate, the qualified candidate will identify, design, develop, fabricate, validate and implement new or improved manufacturing systems. The ideal candidate is an independent thinker and problem-solver capable of diagnosing problems, communicating equally well with production staff and R&D engineers and collaborating within a team environment to provide effective recommendations.

Essential Responsibilities

• Support prototype, V+V and commercial production of disposable medical devices in coordination with the Operations, Product Development and Quality Assurance organizations.
• Identify process improvement opportunities to existing manual operations and manage the design, development, implementation, validation and maintenance of automated or semi-automated manufacturing fixtures, tooling and systems. Areas of focus include component mating and curing, measurement and vision systems, and functional test systems.
• Work with engineers, machinists, designers and Quality Assurance to create detailed electromechanical drawings for new products, product revisions, components, assemblies or tools, typically using CAD technology to create drawings
• Qualify and/or Validate fixtures, tooling and systems via IQ/OQ/PQ, Gage R&R and Process Capability Studies.
• Coordinate fabrication and purchasing activities with outside suppliers
• Ability to work in cross-functional teams in a startup environment. Highly effective communicator of technical status and issues required. Must enjoy team approach over individual contributions.
• Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations. Knowledge of FDA QSR and ISO regulations required.
• Participate in the investigation of failures and formulation and implementation of action plans for all internal corrective actions, audit findings. Address WIP and Incoming MRB in a timely manner.

Experience & Preferred Qualifications

• Minimum of 5 years of experience designing, developing and implementing automated or semi-automated manufacturing fixtures, tooling and systems is required. Medical device experience preferred.
• Knowledge of FDA QSR and ISO regulations required.
• Proficient in CAD. SolidWorks preferred.
• Ability to exercise judgment in selecting, methods, techniques, and evaluation criteria for obtaining results.
• Knowledge of lean, six sigma, kaizen, and continuous improvement initiatives.
• Ability to Communicate ideas and information clearly, effectively, and frequently (oral and written) within the internal project team.

Educational Requirements

• BS in engineering required

Does this look like a good fit?

We’re actively growing our team in Bedford, MA, and would love to hear from you.