Senior Development Engineer
Senior Development Engineer Responsible for the design and development of Sterile Packaging Systems for medical devices per ISO 11607.
Develops functional requirements for User Needs and transfers into Packaging Solutions.
Understands and applies standard such as EU MDR and ISO to ensure packaging system performance.
Ability to use CAD (PROe preferred) to design and communicate with vendors and manufacturing teams, including project teams.
Must have established knowledge in Sterile packaging and the development process to apply Design Control tools.
Position is critical to the EU MDR and FDA requirements for Sterile Packaging development.
Candidate must be able to pro actively engage teams, establish and execute on test protocols for Sterile Barrier Systems for aging, transportation, labeling, etc to meet ISO 11607.
Candidate will engage vendors and mfg teams to ensure design transfer.
Technical report writing is required.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
Develops functional requirements for User Needs and transfers into Packaging Solutions.
Understands and applies standard such as EU MDR and ISO to ensure packaging system performance.
Ability to use CAD (PROe preferred) to design and communicate with vendors and manufacturing teams, including project teams.
Must have established knowledge in Sterile packaging and the development process to apply Design Control tools.
Position is critical to the EU MDR and FDA requirements for Sterile Packaging development.
Candidate must be able to pro actively engage teams, establish and execute on test protocols for Sterile Barrier Systems for aging, transportation, labeling, etc to meet ISO 11607.
Candidate will engage vendors and mfg teams to ensure design transfer.
Technical report writing is required.
.
Estimated Salary: $20 to $28 per hour based on qualifications.
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