Production Builder I
Penumbra
This listing was originally posted on Penumbra's careers page. Formulate is an equal opportunity job aggregator and is not involved in the hiring process. Where salary information is estimated, it is derived from BLS industry benchmarks and may differ from actual compensation.
Upgrade to Pro to access the AI-generated 'Read before applying' briefing and other premium pharma intelligence.
Upgrade to Pro — $25/moGeneral 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. *
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. *
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:
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 class 10,000 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.
Explore related positions you might be interested in
We'll notify you when matching roles are posted.
Interviewed at Penumbra?
Help others prepare — share your experience anonymously.
MEDICAL DEVICES
Vascular / Surgical Devices
Upgrade to Pro to access AI interview prep brief and other premium pharma intelligence.
Upgrade to Pro — $25/mo