- Prototype manufacturing:
- Work with R&D engineers to assemble and test prototype products with little to no defined instruction.
- Assist in development of manufacturing process' working closely with Lab Manager and R&D engineers, including creating work instructions, travelers (e.g., documentation associated to builds) as well as root cause analysis of failed units.
- Product development:
- Work with engineering design partners to teach, learn and assist in the development of new process' and equipment, including readiness for production or training associated with product manufacturing processes.
- This position will work with the New Production Introduction (NPI) team to trouble-shoot production issues and assist in continuous improvement of assembly and test procedures and equipment.
- Clinical manufacturing:
- Oversee the assembly, testing, and documentation needs of manufactured prototypes intended for clinical use.
- Lab supervision:
- Manage and mentor others as instructed by Lab Manager.
- Maintain laboratory supplies and assist Lab Manager as instructed, including lab cleanliness and organization.
- Documentation:
- Maintain accurate documentation per GDP and GMP. This requires a detailed oriented individual with strong organizational and analytical skills, with forward planning abilities, as well as following/establishing/creating necessary documentation and computer skills.
- Quality related:
- Must be able to carry out sampling, testing, measuring, recording, and analyzing of test results as part of a scientific team.
- Support:
- Support sustaining and/or operations, which includes service and repair groups as instructed by Lab Manager.
- Other duties as assigned:
- Must be able to read, understand and execute written test procedures.
- Must be safety minded, prepared to read, understand, and follow safety requirements.
- Ability to assemble small devices requiring fine motor skills under a microscope.
- Experience handling and assembling ferroelectric, piezoelectric or magneto strictive devices.
- Capable of attention to detail, in assembly work, testing and documentation.
- Experience establishing/creating documentation e.g., work instructions, product travelers, etc.
- Capable of using computer skills to create and complete documentation in excel, word etc. for use in work instructions, creating forms to record test results, etc.
- Fine Soldering skills are required for the removal and replacement of electrical components.
- Excellent troubleshooting skills for digital and analog based electronic circuits.
- Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
- Effective interpersonal skills enabling constant constructive communication with engineers, and having the ability to communicate status, technical issues, and general information by various means at all levels in a team-oriented environment.
- 5+ years working as a technician: testing and/or assembly prototype product within a medical device / equipment environment.
- Experience with prototype assembly and analysis within product development environment.
- Associates degree
- Experience assembling and testing electronic or ultrasonic devices.
- Experience with prototype machine shop, medical device and/or electronics industry
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Assembly Laboratory Technician - Raleigh, United States - Merz Pharmaceuticals USA
Description
This position primary responsibility is to assemble and test prototypes products of Ulthera's ultrasonic products that are in R&D development.
Assembly Laboratory Technician will provide and establish themselves as a subject matter expert to R&D engineers regarding the manufacturing process'.
This position requires mechanical aptitude, visual inspection, use of microscopes, documentation and recording of data as well as some quality assurance sampling, testing, and measuring skills using various precise measuring equipment.
ResponsibilitiesTechnical & Functional Skills:
Minimum Qualifications:
Preferred Qualifications:
