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Project Engineer
2 months ago
Contract medical device manufacturer providing full-service solutions for single use and single patient devices across a range of high to low volume needs.
You will contribute to the successful delivery of customer products by planning projects, establishing project criteria, coordinating project reviews, and ensuring the proper implementation of project elements. This will include the specification of equipment, development of manufacturing processes, and the validation of molds for the successful transfer to Manufacturing
What you'll be doing:
- Gathering product requirements from the customer, working with internal and external resources to research, design, and develop the necessary elements of the project - molds, tooling, processes, automation, fixtures, EOAT, secondary equipment, etc.
- Reviewing product designs for compliance with engineering principles, engineering standards and customer requirements and specifications.
- Providing technical support for the customer and internal project team in the areas of product design, material selection, mold design, manufacturing, secondary operations, validations, and other areas related to injection molding and tooling for the development of medical devices.
- Preparing, scheduling, and coordinating assigned engineering projects.
- Controlling budgets, schedules, and personnel performance to report the project's status.
- Utilizing project management techniques with internal and external teams - Action item lists, meeting minutes, strong communication skills, setting priorities, and seeking assistance as required.
- Driving project timelines to support quoted lead-times, and incorporating the customer requirements for validation, pilot builds, and approval.
- Working with the program manager and other project participants to create more efficient project methods and to maintain the project's profitability.
- Reviewing engineering tasks and initiating the necessary corrective actions.
- Completing a successful development so that the customer deliverables, quality, and financial requirements are met.
- Determining test and DOE objectives and contributing to validation protocols.
- Ensuring that mold, process, or assembly testing is performed in a manner that results in a robust manufacturing process.
- Resolving issues that are found during testing.
- Writing and reviewing project reports including validations and summaries.
- Organizing documentation during the project including developing the Device Master Record (DMR) and ensure that internal documentation and systems are up to date at the time of the Release to Manufacturing (RTM).
- Providing internal support for the project after RTM and resolving any new issues that develop.
- Maintaining a safe work environment by following all company safety policies and procedures.
- Bachelor of Science Degree in Plastics Engineering or Mechanical Engineering with Injection Molding experience
- Minimum of 2 years related experience.
- Scientific injection molding principles, RJG Master Molder certification is a plus
- Working knowledge of 3D CAD software. Solidworks is preferred.
- Ability to read, write and communicate in English