Medical Device Assembler I – Cleanroom

Penumbra, Inc.; Salt Lake City (UT); On-site; USD 25,000 - 32,000; Full time

Benefits offered by this job

Medical, dental, vision insurance

401(k) with employer match

Paid parental leave

Eleven paid company holidays

Vacation days increasing with tenure

Paid sick time

Job summary

Penumbra, Inc. in Salt Lake City is seeking a Production Builder I to perform moderately complex assembly and data recording. You will set up and operate manufacturing equipment in a CER and ensure documentation accuracy, while adhering to QMS and safety policies.

The role requires at least 1 year in clean room or medical device manufacturing, strong attention to detail, and manual dexterity for microscope work. On-site, day shift with competitive pay and benefits.

Qualifications

• 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.
• 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

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.
• 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.

Skills

Basic math skills

Attention to detail

Able to comprehend spoken and written英

Effective verbal and written comms

High manual dexterity

Education

High School or equivalent + 1+ year clean room/Mfg experience

Tools

Microscope

Soldering iron

Tweezers

Hand-held tools

Job description

Penumbra, Inc. in Salt Lake City is seeking a Production Builder I to perform moderately complex assembly and data recording. You will set up and operate manufacturing equipment in a CER and ensure documentation accuracy, while adhering to QMS and safety policies.

The role requires at least 1 year in clean room or medical device manufacturing, strong attention to detail, and manual dexterity for microscope work. On-site, day shift with competitive pay and benefits.