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Amgen

#WeareBiotech

Engineer I

EngineerEngineerFull TimeRemoteMid LevelTeam 10,001+Since 1980H1B SponsorCompany SiteLinkedIn

Location

California + 1 moreAll locations: California | Michigan

Posted

4 days ago

Salary

$88.3K - $119.4K / year

Seniority

Mid Level

Bachelor Degree2 yrs expExperience acceptedEnglish

Job Description

Engineer I

Amgen

• You will be part of a development and sustaining device engineering team that supports final product development of Electromechanical Device Platforms. • You will be responsible for ensuring the product meets all requirements for safety, efficacy, and functionality through product lifecycle management. • You will manage the creation and maintenance of design documentation in accordance with quality procedures. • You will be part of multi-functional teams responsible for the development of drug-device combination products. • Providing guidance on combination product and device design requirements and specifications • Leading product test strategies and execution to demonstrate product safety, performance, and efficacy • Manage combination product and device Design History Files • Analyzing data to support design acceptance, performance capability, and failure analysis • Creating and driving test protocols, methods, and reports • Transferring of technical information to manufacturing sites and support manufacturing scale-up and launches • Employ basic engineering skills and practices to gather user requirements and translate them into documentation • Engaging suppliers and development partners regarding specifications and quality levels • Provides authorship and expert technical leadership for regulatory filings • Managing project scope, schedule, and budget • Owns and support quality records, change records, and deviations • Supports device design complaint investigations and tracking to ensure timely resolution and continuous improvement • Collaborate with Process Development and external partners as a technical authority.

Job Requirements

  • Master’s degree
  • Or Bachelor’s degree and 2 years of Engineering and/or Operations experience
  • Or Associate’s degree and 6 years of Engineering and/or Operations experience
  • Or High school diploma / GED and 8 of Engineering and/or Operations experience
  • Bachelor's degree in engineering or other science-related field with 5+ years of relevant work experience with demonstrated ability in operations/manufacturing environment
  • Experience in medical device, pharmaceutical or a similar regulated industry
  • Background in development and commercialization of medical devices, and knowledge of manufacturing processes
  • Understanding of the following standards and regulations: Quality System Regulation – 21CFR820
  • Quality Management System for medical device/component manufacturers - ISO 13485
  • Risk Management for Medical Devices – ISO 14971
  • Excellent communication and technical writing skills.

Benefits

  • A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions
  • group medical, dental and vision coverage
  • life and disability insurance
  • flexible spending accounts
  • A discretionary annual bonus program
  • stock-based long-term incentives
  • Award-winning time-off plans
  • Flexible work models where possible.

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