Equipment Maintenance Technician III (Swing Shift) at Penumbra Inc

Alameda, California, United States

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Medical Devices, ManufacturingIndustries

Requirements

High School or GED with 5+ years of experience working in a medical device or manufacturing environment, or equivalent combination of education and experience
Associate degree preferred
Proven ability to build, troubleshoot, repair and maintain manufacturing equipment per GMP guidelines, preferably in the medical device industry
Medical device, pharmaceutical, biotech, or other regulated industry experience desired
Strong oral, written and interpersonal communication skills
High degree of accuracy and attention to detail
Proficiency with Outlook, MS Word, Excel, and PowerPoint
Excellent organizational skills with ability to prioritize assignments while handling various projects simultaneously
Willingness and ability to work on site, Swing Shift (Monday to Friday, 3:15 PM to 11:45 PM), with weekly overtime required as needed, including potential weekends
Ability to lift and move up to 50 pounds (occasionally up to 100 pounds with assistance), climb ladders up to 12 feet, move between buildings and floors, remain stationary, and work in general office, laboratory, and cleanroom environments with potential exposure to blood-borne pathogens

Responsibilities

Manage and perform maintenance activities including preventative maintenance, on-demand maintenance, and non-standard repairs while documenting activities by following quality system procedures
Collaborate with other technicians: Assist and guide other technicians with performing on-demand maintenance and troubleshooting as needed
Install equipment and complete validation processes such as IQ/OQ (Installation Qualification/Operational Qualification) to ensure proper functionality
Utilize the spare parts system to maintain accurate inventory levels, track usage, and reorder parts when necessary
Analyze and solve equipment-related manufacturing problems and perform manufacturing line support
Educate production staff on proper use and cleaning of equipment, ensuring efficient and safe operations
Assemble equipment and fixtures in accordance with documented prints and collaborate with Engineering to incorporate improvements
Improve equipment documentation by suggesting revisions to Equipment Binders and preventative maintenance instructions for new and existing equipment
Procure equipment and fixtures to support manufacturing
Work independently to solve practical problems encountered
Train equipment technicians on complex equipment repairs and departmental practices
Participate in manufacturing line moves and equipment relocation
Make suggestions regarding equipment and fixtures that may improve throughput, yield, and/or ergonomics, and draft new documentation
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
Perform other work-related duties as assigned

Skills

Preventive Maintenance

Troubleshooting

IQ/OQ Validation

Equipment Installation

Spare Parts Management

Inventory Tracking

Equipment Repair

Manufacturing Support

Equipment Documentation

Technician Training

Fixture Assembly

Quality System Procedures

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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