What are the responsibilities and job description for the Production Builder I/Medical Device Assembler position at Penumbra CPA?

Join Penumbra's Salt Lake City 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.

What You'll Work On :

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.

What You Contribute :

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. The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified

Salt Lake City, UT

Starting Base Pay is $18.00 - $23.00 / hour

Individual compensation will vary over time based on factors such as performance, skill level, competencies, work location and shift.

What We Offer

A collaborative teamwork environment where learning is constant, and performance is rewarded.

The opportunity to be part of the team that is revolutionizing the treatment of some of the world's most devastating diseases.

A generous benefits package for eligible employees that includes medical, dental, vision, life, AD&D, short and long-term disability insurance, 401(k) with employer match, an employee stock purchase plan, paid parental leave, eleven paid company holidays per year, a minimum of fifteen days of accrued vacation per year, which increases with tenure, and paid sick time in compliance with applicable law(s).

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.

Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, age, disability, military or veteran status, or any other characteristic protected by federal, state, or local laws.

If you reside in the State of California, please also refer to Penumbra's Privacy Notice for California Residents.

For additional information on Penumbra's commitment to being an equal opportunity employer, please see Penumbra's AAP Policy Statement.

Salary : $18 - $23

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Production Builder I/Medical Device Assembler

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