Production Builder I

Penumbra, Inc.; Reno (NV); On-site; USD 24,796 - 31,684; Full time

Benefits offered by this job

Medical, dental, vision, life, AD&D, &

Job summary

Penumbra, Inc. in Salt Lake City, UT, is seeking a Production Builder I to assemble medical devices in a cleanroom environment on the day shift. Under supervision, you will perform moderately complex assembly, data recording and basic product testing, following QSR/ISO13485 and company SOPs.

Your responsibilities include set-up of manufacturing equipment, in-process inspection, maintaining cleanliness, and ensuring accurate lot records, with training completed and on-site attendance required.

Qualifications

• High school or equivalent required with 1+ year clean room or manufacturing experience.
• Basic math skills and ability to read and follow procedures.
• Able to comprehend spoken and written English; effective communication.
• Attention to detail and high manual dexterity; familiar with cleanroom protocols.
• Working knowledge of cGMP/QSR requirements and related documentation.

Responsibilities

• Assemble medical devices in a cleanroom per QSR/ISO13485 and SOPs.
• Perform in-process inspection to verify quality conformance.
• Record lot history data and maintain component accountability.
• Set up and operate manufacturing equipment.
• Maintain cleanroom standards and housekeeping per procedures.
• Report process or documentation issues and assist resolutions.
• Complete personal training records and maintain attendance onsite.

Skills

Basic math skills

English proficiency

Effective communication

Attention to detail

Manual dexterity

cGMP/QSR knowledge

Education

High School or equivalent with 1+ year clean room experience

Tools

Microscope

Soldering iron

Tweezers

Job description

General Summary

Under supervision, the Production Builder I performs moderately complex assembly. Performs data recording and product testing.

Specific Duties and 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 cleanroom standards, practices, and housekeeping according to standard operating procedures and the illness and injury prevention program. *
• Clean supplies and manufacturing equipment and work areas. *
• Report 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. *
• Understand relevant security, privacy and compliance principles and adhere 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. *
• Regular, reliable attendance onsite*
• Frequent use of microscope*
• Perform other work-related duties as assigned.

*Indicates an essential function of the role

Position Qualifications

Minimum education and experience:

• High School or equivalent with 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.

Additional qualifications

• Basic math skills
• Able to comprehend spoken and written English
• Effective verbal and written communication skills
• Able to pay close attention to detail
• High manual dexterity
• Basic Working knowledge of cGMP/QSR requirements.
• Able to use tools such as microscope, soldering iron, tweezer, and other hand-held tools

Working Conditions

• Production lab/ Controlled Environment Room (CER)
• Personnel are gowned and work in a class10,000 cleanroom
• Willingness and ability to work on site.
• Potential exposure to blood-borne pathogens
• Requires some lifting and moving of up to 25 pounds
• Must be able to move between buildings and floors.
• Must be able to remain stationary and use a microscope, cleanroom or laboratory equipment, or other standard office equipment, for an extensive period of time each day. Will need to use a computer for email, trainings, procedures, etc.
• Must be able to communicate and exchange accurate information with employees at all levels on a daily basis.

Salt Lake City, UT

Day Shift

Base Pay Range Per Hour: $18.00 - $23.00

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, 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.