R&D Process Development Engineer
The Process Development Engineer is responsible for the designing and optimizing of processes required to manufacture new medical devices.
Identify and evaluate innovative processing options based on product attributes for products, including evaluation based on technical and economic feasibility.
Execute cost-effective systems in order to enhance the speed and quality of processing, and ensure produced items comply with government regulations and industry standards.
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- The manager is looking for candidates with CREO and process development experience. Candidates must have 3-5 years of solid engineering experience.
- Must have Bachelors Degree in Engineering
ESSENTIAL JOB FUNCTIONS / DUTIES :
Collaborate in a team of engineers focused on design, development, and implementation of new processes required for the manufacture of new device designs.
Execute methods needed for efficient and effective process development (design for manufacturing, test method validation, process validation, process capability, lean manufacturing, equipment selection and specification development).
Utilize a risk based approach is applied during the development implementation and validation of all processes.
Responsible for process documentation (PFMEA’s, Production Instructions, Drawings etc.) associated with new products.
Collaborate with R&D team, Operations, and Production engineering to ensure the effective completion of all activities associated with transfer to manufacturing of an R&D Engineering project / objective.
Compare costs and benefits when choosing product in-house or supplier selection.
Define, identify, and procure new equipment for manufacturing processes
Ability to complete projects within specific time lines and meeting performance expectations.
Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable regulatory requirements.
MINIMUM WORK EXPERIENCE / EDUCATIONAL REQUIREMENTS :
Bachelor's degree in Engineering,
Experience in creating process validation documents with knowledge in design for manufacturing, statistics and lean manufacturing principles
Experience in identifying process variation, process capability and evaluation and DOE's.
Experience commissioning and qualification of new processes equipment
Minimum of 3 years’ experience working in Class II / III medical device manufacturing or GMP regulated environment
Knowledge of process validation, design for manufacturing, statistics and lean manufacturing principles.
Knowledge of medical device quality standards ISO13485 / FDA practices, MP and similar regulated industry standards.
Experience using analytic skills and problem solving
Working knowledge of Microsoft Office Software (i.e. Word, Excel, Visio, Power point, MS Project)
Preferred knowledge of 3D Modeling software (Creo, Solid Works, etc.)
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