Engineer II
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Job Description
Engineer II role at biotech company focusing on electromechanical device development and lifecycle management. Responsibilities include ensuring product safety, performance, and collaboration with multi-functional teams.
Responsibilities:
- 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.
- 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.
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, 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.
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