What you will be doing:
● Suiting up and working in a cleanroom environment to assemble components, subassemblies and final products (catheters, implants) with care and precision while working under a microscope.
● Following the protocols of a medical device quality system (ISO 13485) that will be trained and provided through your onboarding
● Maintaining appropriate documentation throughout the assembly and test processes.
○ In the Medical Device industry, quality is paramount and completing detailed documentation is required by government agencies, such as the FDA. Being willing to complete documentation and enter information into computer systems with extreme attention to detail is a critical aspect of the position.
● Performing product testing and reporting any non-conformances to supervisors and quality or engineering partners.
● Performing in-line quality checks utilizing hand tools, calipers, rulers, etc.
● Using precision tooling and performing assembly tasks under a microscope that include soldering, gluing, braiding, coiling, laser or RF welding, stitching, sewing, etc.
● Operating various equipment, such as adhesive dispensers and UV cure machines to complete complex assembly tasks
● Working with teams to drive lean manufacturing and continuous improvement initiatives as new products are introduced into manufacturing from R&D
What we are looking for:
● Advanced knowledge of electrical or mechanical product manufacturing or assembly processes achieved through education, certifications or professional experience
● Ability to problem solve, critically think and troubleshoot electro-mechanical products or systems
● Comfortable with precision assembly tasks performed under a microscope
○ This is important to note. Working under a microscope involves special ergonomic considerations such as sitting still, holding your hands steady, having good vision when inspecting parts
● Comfortable working in a clean room environment
○ While cleanroom protocols will be taught, please be aware that you will have to wear hair nets, gloves, clothing and shoe covering and at times masks and safety glasses when performing assembly tasks and in the classroom.
● Understanding of and/or interested in quality systems or procedures
○ Have you worked around quality or know any quality requirements? (ISO 9001, IOS 13485, etc.)?
○ Have you participated in any inspection processes of products?
○ Have you filled out any quality related documentation?
○ Do you have any experience working in a regulated environment?
○ While we can teach you most, any experience will help!
● Ability to fill out technical documentation
○ Documentation is critical to the Medical Device industry
○ Being able to read and write English, take detailed notes and write legibly is important because it is a standard part of the day to day!
● Comfortable with computers
○ We also track defects and production data in our ERP system. We are looking for partners who are comfortable working on computers!
● Passionate about manufacturing and contributing to continuous improvement
○ If you have knowledge surrounding safety, lean manufacturing, six sigma, process or continuous improvement activities (Kaizen, 6S, Kanban, etc.) please let us know! While this is not a hard requirement, you will get exposure to lean manufacturing projects and we would love to know your experience here!
○ Having a mindset for continuous improvement and being on the lookout for how we can do things better is encouraged!
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