Responsibilities:
- Creates and improves processes pertaining to:
- Feasibility Builds, Manufacturing, and Inspection
- Planning and executing process characterization activities, through tools i.e. design experiments
- Equipment selection
- Process development and documentation
- Component validation and verification samples and testing
- Develops and executes IQ, OQ and PQ protocols and reports
- Operator training
- Process Failure Mode Effects Analysis
- Clinical Builds
- Process Validation
- Assembly and Component Process flow layouts
- Involved with manufacturing and product design teams to:
- Facilitate and create processes
- Implement systems to produce a quality and cost effective product
- Improve Labor cycle times
- Improve existing processes for boosting productivity, quality and cost
- Assist with the preparation of proposals and quotes for customers
- Creates process risk assessments
- Assesses safety requirements ensuring they are part of the process for the builder, user and customer
- Prepares Engineering Change Orders for processes, components, and Bill of materials
- Performs and advises Corrective and Preventive Action tasks
- Other Duties as assigned
Requirements:
- FDA cGMP principles and practices
- Must have 3 or more years’ experience of medical device process or manufacturing engineering
- 2 years’ experience with bonding techniques. I.E. - Adhesives, Chemical, Laser, Resistance welding
- Familiarity with biocompatible materials
- Exposure to Pro-E / CREO and or SolidWorks preferred
- Strong computer skills associated with Microsoft software
- Demonstrated ability to interpret technical drawing, blueprints, specification and illustrations
- Possess a keen attention to detail
- Must be able to read, write and speak fluent English
- Excellent reading, writing, communication, and organizational skills
- Demonstrated ability for systematic problem solving, DMAIC
- Maintains performance with changing priorities under minimal supervision
- Must maintain high ethical standards
- Must be able to make clear and accurate decisions
- Ability to learn and apply new technology
- Must have a BS degree in relevant engineering discipline with a minimum 3 years of related engineering experience