[Remote] Engineer II

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.ResponsibilitiesProviding guidance on combination product and device design requirements and specificationsLeading product test strategies and execution to demonstrate product safety, performance, and efficacyManage combination product and device Design History FilesAnalyzing data to support design acceptance, performance capability, and failure analysisCreating and driving test protocols, methods, and reportsTransferring of technical information to manufacturing sites and support manufacturing scale-up and launchesEmploy basic engineering skills and practices to gather user requirements and translate them into documentationEngaging suppliers and development partners regarding specifications and quality levelsProvides authorship and expert technical leadership for regulatory filingsManaging project scope, schedule, and budgetOwns and support quality records, change records, and deviationsSupports device design complaint investigations and tracking to ensure timely resolution and continuous improvementCollaborate with Process Development and external partners as a technical authoritySkillsMaster's degreeBachelor's degree and 2 years of Engineering and/or Operations experienceAssociate's degree and 6 years of Engineering and/or Operations experienceHigh school diploma / GED and 8 of Engineering and/or Operations experienceBachelor's degree in engineering or other science-related field with 5+ years of relevant work experience with demonstrated ability in operations/manufacturing environmentExperience in medical device, pharmaceutical or a similar regulated industryBackground in development and commercialization of medical devices, and knowledge of manufacturing processesUnderstanding 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 14971Excellent communication and technical writing skillsBenefitsA 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 accountsA discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plansFlexible work models where possible. Refer to the Work Location Type in the job posting to see if this applies.Company OverviewAmgen is a biotechnology company that develops and manufactures human therapeutics for various illnesses and diseases. It was founded in 1980, and is headquartered in Thousand Oaks, California, USA, with a workforce of 10001+ employees. Its website is http://www.amgen.com.Company H1B SponsorshipAmgen has a track record of offering H1B sponsorships, with 42 in 2026, 429 in 2025, 485 in 2024, 485 in 2023, 540 in 2022, 460 in 2021, 444 in 2020. Please note that this does not guarantee sponsorship for this specific role.