Engineer I - Detroit MI

Engineer I

In this vital role 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.

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