Production Builder I/Medical Device Assembler

1 week ago

Salt Lake, Utah, United States Penumbra Full time
Join Penumbra's Team

As a Production Builder/Medical Device Assembler, you will be part of a dynamic team helping make products that save lives every day. You'll work in a clean-room laboratory environment, where your main responsibility will be the assembly of medical devices following Good Manufacturing Practices (GMP) guidelines.

Key Responsibilities:
• Assemble medical devices according to Federal QSR, ISO 13485, lot history records, manufacturing instructions, standard operating procedures, and safety policies.
• Perform in-process inspection of components and assemblies to verify quality conformance.
• Record information on lot history records and perform component accountabilities.
• Set-up and operate manufacturing equipment.
• Maintain clean room standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program.
• Clean supplies and manufacturing equipment and work areas.
• Reports causes of process and/or documentation issues and assists in resolution.
• Responsible for completion of personal training records.
• Adhere to the Company's Quality Management System (QMS) as well as domestic and global quality system regulations, standards, and procedures.
• Understands relevant security, privacy, and compliance principles and adheres to the regulations, standards, and procedures that are applicable to the Company.
• Ensure other members of the department follow the QMS, regulations, standards, and procedures.
• Perform other work-related duties as assigned.

Requirements:
• Minimum education: High School or equivalent.
• Minimum experience: Minimum 1-year clean room assembly experience or manufacturing.
• Experience in the medical device, pharmaceutical, or biotech industry, or equivalent combination of education and experience required to perform at this level.
• Skills: Basic math skills.
• Able to pay close attention to detail.
• Basic Working knowledge of cGMP/QSR requirements.
• Able to use tools such as microscope, soldering iron, tweezers, and other hand-held tools.
• An interest in health care and/or manufacturing, and the desire to learn something new every day.
• The ability to actively participate in a teamwork environment that maintains a high-performance culture.

Working Conditions:
Personnel are gowned and work in a class 10,000 clean room. Requires some lifting and moving of up to 25 pounds. The employee is frequently required to stand, walk, sit, and reach with hands and arms, and to use a computer, sitting for extended periods. Specific vision abilities required by this job include ability to read, close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies. Penumbra designs, develops, manufactures, and markets novel products and has a broad portfolio that addresses challenging medical conditions in markets with significant unmet need. Penumbra sells its products to hospitals and healthcare providers primarily through its direct sales organization in the United States, most of Europe, Canada, and Australia, and through distributors in select international markets. The Penumbra logo is a trademark of Penumbra, Inc.

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