Production Builder I/Medical Device Assembler at Penumbra Inc

Salt Lake City, Utah, United States

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Not SpecifiedCompensation

Entry Level & New GradExperience Level

Full TimeJob Type

UnknownVisa

Medical DevicesIndustries

Requirements

High School diploma or equivalent
Minimum 1-year clean room assembly experience or manufacturing experience
Experience in the medical device, pharmaceutical, or biotech industry, or equivalent combination of education and experience
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
Interest in health care and/or manufacturing, and desire to learn something new every day
Ability to actively participate in a teamwork environment that maintains a high-performance culture
Ability to lift and move up to 25 pounds
Ability to stand, walk, sit, reach with hands and arms, and use a computer for extended periods
Specific vision abilities: read, close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus

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, manufacturing equipment, and work areas
Report causes of process and/or documentation issues and assist in resolution
Complete 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 applicable regulations, standards, and procedures
Ensure other members of the department follow the QMS, regulations, standards, and procedures
Perform other work-related duties as assigned

Skills

GMP

ISO 13485

QSR

clean room assembly

in-process inspection

lot history records

manufacturing equipment

Quality Management System

basic math

Penumbra Inc

Develops medical devices for vascular conditions

About Penumbra Inc

Penumbra Inc. specializes in creating medical devices aimed at treating neurovascular and peripheral vascular conditions. Their products, such as the Penumbra System and the Indigo System, are designed for use in hospitals and clinics, helping healthcare professionals address issues like stroke and other vascular diseases. These devices work by providing advanced tools for interventions in neurology and vascular surgery, allowing for effective treatment options. Unlike many competitors, Penumbra focuses specifically on these specialized areas, ensuring their products are tailored to the needs of medical professionals in these fields. The company's goal is to continuously improve and innovate their medical devices to enhance patient care and support healthcare providers in delivering effective treatments.

Alameda, CaliforniaHeadquarters

2004Year Founded

$116.7KTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

1,001-5,000Employees

Benefits

Health Insurance

Dental Insurance

Vision Insurance

Life Insurance

Disability Insurance

401(k) Retirement Plan

401(k) Company Match

Paid Parental Leave

Paid Vacation

Paid Sick Leave

Paid Holidays

Risks

Recent layoffs in the Immersive Healthcare division may indicate financial strain.

The EMBOLIZE trial could divert resources from core product lines.

Regulatory challenges in Europe may impact sales of new products like BMX81 and BMX96.

Differentiation

Penumbra offers a comprehensive range of neuro and peripheral vascular devices.

The company focuses on innovative solutions for stroke and neurovascular disease treatment.

Penumbra's global presence spans North America, Europe, Asia, and Australia.

Upsides

Growing demand for minimally invasive procedures aligns with Penumbra's product offerings.

The global neurovascular devices market is projected to grow at 8.5% CAGR until 2030.

Penumbra's European launch of BMX81 and BMX96 expands its market presence.

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