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Equipment Engineer
Whitridge Associates • Burlington, MA 01805 • Posted 1 day ago via LinkedIn
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In-person • Full-time • Mid Level
Job Highlights
Using AI ⚡ to summarize the original job post
The Equipment Engineer at Whitridge Associates is responsible for identifying process improvement opportunities in manual operations and managing the design, development, implementation, validation, and maintenance of automated or semi-automated manufacturing fixtures, tooling, and systems. This role involves working closely with engineers, machinists, designers, and Quality Assurance to create detailed electromechanical drawings for new products, product revisions, components, assemblies, or tools. The position requires knowledge of FDA QSR and ISO regulations and involves coordinating with outside suppliers and participating in cross-functional teams.
Responsibilities
- 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.
- 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&D and Process Capability Studies.
- Coordinate fabrication and purchasing activities with outside suppliers.
- Support and enforce company goals and objectives, policies and procedures, Good Manufacturing Practices, Good Documentation Practices, FDA QSR and ISO regulations.
- 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.
Qualifications
Required
- Knowledge of FDA QSR and ISO regulations
Full Job Description
• 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.
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