#WeareBiotech
Engineer I
Location
California + 1 moreAll locations: California | Michigan
Posted
4 days ago
Salary
$88.3K - $119.4K / year
Seniority
Mid Level
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.
Related Guides
Related Categories
Related Job Pages
More Engineer Jobs
Forward Deployed Engineer – CloudFlare
Truelogic SoftwarePremium boutique software development company that helps brands with big ideas to make a difference in people’s lives.
• Lead the architecture, implementation, and migration of Cloudflare-based solutions for enterprise customers. • Design secure, scalable web infrastructure leveraging Cloudflare Application Security, Workers, Workers AI, and Zero Trust capabilities. • Implement and manage infrastructure using Terraform and Infrastructure as Code (IaC) best practices. • Serve as the primary technical advisor, guiding customers through architecture decisions, troubleshooting, and optimization. • Partner with Product, Engineering, and Support teams to resolve complex technical challenges and advocate for customer needs. • Collaborate with customers in fast-paced, Slack-first environments, providing clear technical guidance and timely solutions. • Drive the adoption of AI-driven security and cloud-native technologies aligned with customer objectives. • Identify opportunities to expand security capabilities, including Network Security and SASE architectures.
Forward Deployed Engineer – CloudFlare
Truelogic SoftwarePremium boutique software development company that helps brands with big ideas to make a difference in people’s lives.
• Lead the architecture, implementation, and migration of Cloudflare-based solutions for enterprise customers. • Design secure, scalable web infrastructure leveraging Cloudflare Application Security, Workers, Workers AI, and Zero Trust capabilities. • Implement and manage infrastructure using Terraform and Infrastructure as Code (IaC) best practices. • Serve as the primary technical advisor, guiding customers through architecture decisions, troubleshooting, and optimization. • Partner with Product, Engineering, and Support teams to resolve complex technical challenges and advocate for customer needs. • Collaborate with customers in fast-paced, Slack-first environments, providing clear technical guidance and timely solutions. • Drive the adoption of AI-driven security and cloud-native technologies aligned with customer objectives. • Identify opportunities to expand security capabilities, including Network Security and SASE architectures.
Forward Deployed Engineer – Technology Industry
Truelogic SoftwarePremium boutique software development company that helps brands with big ideas to make a difference in people’s lives.
• Lead the architecture, implementation, and migration of Cloudflare-based solutions for enterprise customers. • Design secure, scalable web infrastructure leveraging Cloudflare Application Security, Workers, Workers AI, and Zero Trust capabilities. • Implement and manage infrastructure using Terraform and Infrastructure as Code (IaC) best practices. • Serve as the primary technical advisor, guiding customers through architecture decisions, troubleshooting, and optimization. • Partner with Product, Engineering, and Support teams to resolve complex technical challenges and advocate for customer needs. • Collaborate with customers in fast-paced, Slack-first environments, providing clear technical guidance and timely solutions. • Drive the adoption of AI-driven security and cloud-native technologies aligned with customer objectives. • Identify opportunities to expand security capabilities, including Network Security and SASE architectures.
Forward Deployed Engineer – CloudFlare
Truelogic SoftwarePremium boutique software development company that helps brands with big ideas to make a difference in people’s lives.
• Customer Engagement & Technical Leadership: Serve as a trusted advisor to key enterprise customers, providing technical insights, best practices, and strategic recommendations that support their business goals and drive success with Cloudflare’s solutions in particular Cloudflare’s worker and workers AI platforms. • Lead architectural discussions, design sessions, and solution reviews to ensure the optimal application of Cloudflare’s offerings in customer environments. Diagnose complex technical issues and deliver effective, strategic solutions in collaboration with the support and product teams. • Architect Application Security: Design and configure comprehensive, tailored solutions with a focus on Application Security, utilizing Cloudflare Workers to optimize and direct global traffic and Network Security. • Master Infrastructure as Code: Support the account team by navigating and managing complex configurations heavily reliant on Terraform to ensure seamless operational stability. • Act as a Strategic Liaison: Serve as a high-speed conduit between the customer and internal Cloudflare teams (Product, Support, Engineering), effectively advocating for customer needs and influencing product roadmaps. • Navigate Modern Communication: Manage complex, fast-moving technical discussions primarily through Slack, acting as a guide for the customer even when formal calls are difficult to schedule. • Drive AI Innovation: Leverage your deep knowledge of AI/LLM concepts to align Cloudflare’s capabilities with the customer’s AI-focused culture and future technological goals. • Provide Long-Term Guidance: Stay with the account post-migration as a trusted advisor to identify future strategic initiatives, including a transition into Network Security and SASE architectures

