Note: The job is a remote job and is open to candidates in USA. Amgen is a leading biotechnology company dedicated to serving patients with serious illnesses. The Engineer II will be part of a device engineering team focused on the development and sustaining of electromechanical device platforms, ensuring product safety, efficacy, and functionality through lifecycle management.

Responsibilities

• 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

Skills

• Master's degree
• Bachelor's degree and 2 years of Engineering and/or Operations experience
• Associate's degree and 6 years of Engineering and/or Operations experience
• 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, 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
• Flexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.

Company Overview

Company H1B Sponsorship