Lab Test Technician - Medical Devices (Mechanical Platforms)

    • Amgen Inc
  • Posted 30 days ago | Updated 11 hours ago

Overview

On Site
Full Time

Skills

Attention to detail
Medical devices
Systems engineering
Process engineering
Product development
Test equipment
Automated testing
Design controls
S-PLUS
Laboratory equipment
Development testing
Product design
Lifecycle management
Process optimization
Quality management
ISO 13485
Risk management
Mechanical engineering
Value engineering
Leadership
Biotechnology
Operations
Testing
Documentation
Planning
Reporting
SAFE
Design
FOCUS
Specification
Expect
GMP
Metrology
Inspection
Prototyping
Design of experiments
Statistical process control
IQ
OQ
PQ
FMEA
Policies
Manufacturing
ISO 9000
Electrical engineering
Finance
Insurance
Sales
Business intelligence

Job Details

HOW MIGHT YOU DEFY IMAGINATION?

You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Lab Test Technician - Combination Product Operations - Mechanical Platforms

Live

What you will do

Let's do this. Let's change the world. In this vital role you will support testing of Amgen's autoinjector and combination product drug delivery systems. The Lab Test Technician possesses experience and expertise in coordinating and implementing complex testing, analysis, and documentation supporting the development of commercial medical devices. In support of Amgen's mission to serve patients, the Combination Product Operations group works to identify, develop, commercialize, and continuously improve drug delivery devices to optimize the patient experience. This position directly supports mechanical autoinjector platform engineers responsible for meeting fast paced development timelines. The Test Technician may also interact with global and multi-functional members from systems engineering, process engineering, device development, packaging, primary containers, device quality, and other groups. Responsibilities of this position include the planning, execution, solving, and recording/reporting of critical test activities to support combination product development.

Responsibilities:
  • Hands on testing and conditioning of autoinjector devices following established and developmental procedures.
  • Safe and accurate operation of complex test equipment, such as Instron tensile tester, digital balances, and automated test equipment.
  • Coordinates with Test Program Leads (TPL), supervisors, and external test vendors to achieve daily, weekly, and monthly test output breakthroughs.
  • Thoroughly and accurately documents test activities and results within digital lab notebooks, per Amgen's internal procedures, and in line with common Good Documentation Practices.
  • Solves problems and provides technical expertise to Sr. Engineers for observations encountered during testing.
  • Identifies test abnormalities/anomalies/unexpected results and clearly communicate these observations to development engineering team.
  • Supports design control and technical documents including test/verification plans, test protocols, test reports, engineering assessments, design outputs, and technical recommendations.
  • Ensures tests methods and test protocols are continuously reviewed and updated in a sound and robust framework with high focus on eliminating test errors.
  • Prepares communications to Sr. Engineers in support of recommendations and assessments.
  • Develops, complete, and reviews mechanical specifications, development plans, characterization plans, and other related development documents for assigned projects.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is a self starter with these qualifications.

Basic Qualifications:

-High school/GED + 4 years of directly related GMP work experience OR
-Associate's + 2 years of directly related GMP experience OR
-Bachelor's + 6 months of directly related GMP experience
-Master's

Preferred Qualifications:
  • 1 or more years of experience as a test or metrology technician in a medical device field.
  • Experience leading complex mechanical test/metrology efforts, including safe and proper operation of lab equipment (Instron tensile tester, Keyence inspection equipment, etc.)
  • Experience handling medical devices containing sharps and/or drug product.
  • Familiar with Good Documentation Practices and their application.
  • High attention to detail, specifically in following and implementing established and in development test procedures and documenting results in digital lab notebooks.
  • Ability to identify test abnormalities/anomalies/unexpected results and clearly communicate these observations to development engineering team.
  • Capable of working on different projects in a deadline driven environment.
  • Experience in drug/device combination product design and development.
  • Background in development, commercialization, and lifecycle management of medical devices.
  • Experience with material & test specification generation, protocol/report authorship, process and test development, prototyping, design verification, DOE/SPC process optimization & validation (IQ, OQ, PQ), FMEA.
  • Knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations as they apply to this job type/position.
  • Familiar with the following standards: US Good Manufacturing Practices (21CFR820), Quality Management (ISO 13485), Risk Management (ISO 14971), EU Medical Device requirements (Council Directive 93/42/EEC), and Medical Electrical Equipment (EN 60601)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well-being.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and bi-annual company-wide shutdowns
  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

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