Manufacturing Technician

Job purpose

Utilizes knowledge and skills in the manufacturing of components into finished devices, in compliance with regulatory and company guidelines. Ability to perform complex, precision tests or tasks and the ability to learnt to operate a laser welding system. Performs a variety of tasks from repetitive to non-repetitive. Must have the ability to participate in the development of manufacturing processes, and documentation of work procedures. Will conduct quality inspections in accordance with quality specifications and work instructions.

Duties and responsibilities

• Use higher level tools and equipment to complete highly complex stages of assembly of medical devices precisely and in a timely fashion.
• Operate laser welding system and verify laser welding system settings in accordance with manufacturing instructions.
• Perform precision and difficult assembly of small delicate components under a microscope
• Follow Manufacturing and/or Engineering instructions and drawings, using computers to navigate drawings.
• Inventory reconciliation at beginning and end of workday when transitioning to next WO.
• Review, follow and perform job functions in compliance with established work instructions and adherence with SOPs, including recording traceable information on device history records.
• Perform line clearance, i.e., cleaning and sanitizing workstations at the start/end of shift and when transitioning to next WOs. Ensure all required components and tools are ready for the build.
• Self-assessment of work, which may include visual inspection under a microscope, and sequential review of colleague’s work, providing constructive team feedback, including escalating work issues and changes in equipment performance to Supervisor for assessment and correction.
• On time arrival to work, regular attendance without excessive absenteeism, and working a full 8 hours or longer work period
• General work area cleaning
• Will work in an ISO Class 7 clean room

Qualifications

• Experienced with the standards and requirements of the medical device industry
• Must have working knowledge of GDP, line clearance, DHR
• Knowledge of NCMR documentation, segregation, and processing is a plus
• Strong written and verbal communication skills
• Collaboration skills – must be able to work closely with assemblers, technicians, engineers, quality assurance, supervisors
• Ability to read, write, and follow technical documents
• Computer knowledge and skills, proficiency in MS Office Suite (i.e., Word, Excel, Outlook)
• Laser welding experience is a plus

Education and Experience Requirements:

• Requires a high school diploma or equivalent.
• Typically requires 5-7 years of related experience.
• Working knowledge of management quality system requirements for medical devices (ISO 13485:2016, ISO 14971:2019, (EU) 2017/745, FDA 21 CFR 820) is a plus