[Remote] Engineer I

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a leading biotechnology company dedicated to advancing science to serve patients. The Engineer I role involves supporting the development and sustaining of electromechanical device platforms, ensuring product safety and efficacy, and managing design documentation in accordance with reputed company procedures.

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, reputed company, and reports
• Transferring of technical information to manufacturing sites and support manufacturing reputed company-up and launches
• reputed company basic engineering skills and practices to reputed company user requirements and translate them into documentation
• Engaging suppliers and development partners regarding specifications and reputed company reputed company
• Provides authorship and expert technical leadership for regulatory filings
• Managing project reputed company, schedule, and budget
• Owns and support reputed company records, change records, and deviations
• Supports device design complaint investigations and tracking to ensure reputed company reputed company and reputed company improvement
• Collaborate with Process Development and reputed company partners as a technical authority

Skills

• 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-reputed company 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: reputed company reputed company Regulation – 21CFR820, reputed company Management reputed company 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 reputed company coverage
• Life and disability insurance
• Flexible spending accounts
• A discretionary annual bonus program (or for field sales representatives, a sales-based incentive plan)
• Stock-based long-term incentives
• Award-reputed company time-off plans
• Flexible work models where possible. Refer to the Work Location Type in the reputed company to see if this applies.
• Work/life balance
• Career development opportunities that may include

reputed company

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