SUMMARY: Attributes required for this position include ability to follow instructions, meet schedules and priorities, have excellent attention to detail, initiative, work well within a team, and produce consistently high-quality results. Employees must have a good mechanical aptitude and work ethic.
Manufacturing engineer needed with an interest in R&D and production medical manufacturing background in the following processes:
Catheter Manufacturing
RF Tipping
Pad Printing
Braiding/Coiling
Injection Molding
Extrusion
The expectations of the engineer are as follows:
Perform process development activities in the processes listed above.
Support R&D and production processes to ensure that jobs are started, performed and finished accurately and efficiently.
Serve as the primary contact for customer communication.
Assess project needs for quote development with sales staff
Meet quality standards and specifications for all R&D and production builds.
Design, assemble, setup, debug, installation of process, assembly fixtures and equipment.
Communicate effectively with operators, technicians, engineering and management so that all findings or issues are documented and resolved.
Create, or update documents to reflect new, or current practices
Setup and changeover of production equipment per manufacturing instructions.
Train production personnel the operation and changeover process and advise on possible improvements to the process to increase productivity and quality.
Maintain a clean and safe work environment by identifying safety hazards and recommending and/or implementing corrective actions when necessary.
Be a role model on the production floor and make sure that others around you are performing their jobs safely and correctly.
Bachelor’s Degree in an Engineering discipline with 2 years’ minimum experience in a regulated manufacturing environment is required
Catheter design and/or catheter process development experience a plus
Must have mechanical aptitude w/strong troubleshooting skills in machinery and processes
Must be able to read and understand drawings
ISO 13485 experience is a plus
Must be computer literate and work comfortably in Microsoft Office
Intermediate math skills are required
Must be self-motivated and have initiative in driving and completing projects
Must be able to communicate both written and verbally at all levels of the organization
Must have experience executing DOEs and validations
