Engineer I

About the role

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

Qualifications

Basic Qualifications:

• 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 years of Engineering and/or Operations experience

Preferred Qualifications:

• 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 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 21 CFR 820, Quality Management System for medical device/component manufacturers - ISO 13485, Risk Management for Medical Devices ISO 14971
• Excellent communication and technical writing skills

Pay

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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