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- Employment
- Full-time
About the role
What You’ll Do:
- Assemble instrument and consumable assemblies with high quality and consistency for use in prototype testing as well as formal verification and validation testing;
- Perform in-process and final inspection and test of assemblies, creating records for completed units as well as initiating non-conformance reports where needed;
- Set up, operate, and monitor automated and semi-automated equipment used in the assembly process;
- Use microscopes, torque tools, fixtures and measurement devices to complete assembly steps accurately;
- Collaborate in the development, setup, and maintenance of cGMP processes as we transition from prototype assembly processes to production-scale processes;
- Provide feedback and recommendations to the manufacturing engineers for improvements to manufacturing work instructions, assembly, and test fixtures and processes;
- Maintain accurate records of production, including taking inventory of production and prototype materials through cycle counting and physical inventories;
- Apply 5s and lean principles to maintain organization and good housekeeping practices in the manufacturing area;
- Work with Engineering and Assay Development teams to incorporate improvements into the manufacturing process based on testing results and observations;
- Participate in process FMEAs and risk identification as well as assisting with the implementation of appropriate countermeasures;
- Assist Manufacturing Engineering in the setup and validation of new equipment for use in the assembly process;
- Execute daily, weekly, and monthly preventive maintenance and cleaning activities of equipment and manufacturing areas;
- Support and participate in root cause investigations for, Out-of-Specification (OOS) investigations, Quality Incident Notifications, and CAPA actions related to manufactured products and manufacturing processes.
What You’ll Need:
- High school diploma;
- 3+ years of industry experience in medical device or electronic assembly, preferably in a cGMP environment;
- Excellent manual dexterity and visual acuity;
- Ability to read, understand and follow written assembly and test instructions and maintain high levels of accuracy
- Excellent communication skills and attention to detail;
- Strong organizational skills and ability to multitask across projects and activities;
- Proven ability to collaborate cross-functionally and participate in multi-disciplinary teams.
- Experience working with reagents and use of pipettes and liquid measuring equipment
- Experience with optical alignments, microfluidics or sensor based instruments
- Experience with 5s, kanbans, and lean manufacturing processes;
- Prior experience with single-use cartridge assembly, reagent fill and seal, or complex instrument assembly would be welcomed;
- An appreciation of puns!
Why Join Us?
- Get an opportunity to shape the future of medical diagnostics and make a meaningful impact on global healthcare;
- Be in collaborative environment with a high-performing team dedicated to innovation and excellence;
- Have a platform to showcase your talents and grow professionally in a company that values your contributions.
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