The Assembler supports manufacturing tasks as needed to meet R&D and production requirements, using released documentation, LHRs and MPIs.

Once trained the Assembler can perform processes for making assemblies and sub-assemblies, with minimal supervision and minimal instruction.

The Assembler can work from drawings, diagrams, MPI's and SOPs, in accordance with GMP regulations. Brings any discrepancies or nonconformities to the attention of supervisors in a timely manner.

May conduct in process quality inspections in accordance with quality specifications.

Responsibility

• Performs medical device assembly operations in accordance with approved manufacturing procedures and GMP requirements, while maintaining high quality standards.
• Assists in implementing methods and procedures to control or modify the manufacturing process.
• Ensures that product quality is maintained through procedure adherence; identifies product quality deficiencies; raises potential quality issues to supervisor.
• Performs in-process quality checks on product at all levels using measurement tools of varying complexity i.e. optical measurement system, tensile tester
• Utilize small hand tools, calibrated instruments, measurement equipment, microscopes, and test fixtures.
• May assist engineers to resolve line issues. Encouraged to openly suggest opportunities to improve product quality, reduce assembly cycle time and production efficiency.
• Maintain clean room integrity via proper gowning techniques and adherence to clean room environment practices and procedures.
• Maintain accurate records / documentation related to quality, work in progress, test results and labor (e.g. timecards, DHR's).
• Adhere to general safety rules, manufacturing procedures, company policies and procedures, QSR, Good Manufacturing Practices, and FDA regulations.
• Work all required overtime as requested by supervisor.

Qualifications

• High school diploma or equivalent preferred.
• Experience with medical device manufacturing is a must.
• 1-3 years of experience in medical device assembly.
• Ability to read, write, and comprehend English.
• Must have a high level of hand-eye coordination and manual dexterity to work with small plastic and metal components in a high-volume manufacturing setting.

Benefits (employee contribution) :

• Health insurance
• Health savings account
• Dental insurance
• Vision insurance
• Flexible spending accounts
• Life insurance
• Retirement plan

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Last updated : 2024-04-24