Production Builder I/Medical Device Assembler jobs in United States
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Penumbra, Inc. · 2 months ago

Production Builder I/Medical Device Assembler

Penumbra is a global healthcare company focused on innovative therapies, seeking a Production Builder/Medical Device Assembler to join their team in Salt Lake City. The role involves assembling medical devices in a clean-room environment while adhering to strict quality and safety guidelines.

Medical Device
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H1B Sponsor Likelynote

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

Qualification

Clean room assembly experienceCGMP/QSR knowledgeBasic math skillsMedical device experienceInterest in healthcareAttention to detailTeamwork

Required

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

Benefits

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
Paid sick time in compliance with applicable law(s)

Company

Penumbra, Inc.

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Penumbra, Inc., headquartered in Alameda, California, is a global healthcare company focused on innovative therapies.

H1B Sponsorship

Penumbra, Inc. has a track record of offering H1B sponsorships. Please note that this does not guarantee sponsorship for this specific role. Below presents additional info for your reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (36)
2024 (42)
2023 (46)
2022 (43)
2021 (36)
2020 (26)

Funding

Current Stage
Late Stage

Leadership Team

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Adam Elsesser
CEO
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Frances Palmer-Smith
Chief Trust Officer
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Company data provided by crunchbase