Career CategoryEngineering
Job DescriptionEngineer IIWhat you will doLet's do this. Let's change the world. 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.
What we expect of youWe are all different, yet we all use our unique contributions to serve patients. The Engineer professional we seek is an individual with these 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 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 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
What you can expect of usAs we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we'll support your journey every step of the way.
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.
In addition to the base salary, Amgen offers a Total Rewards Plan, based on eligibility, comprising of health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities that may include:
- 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. Refer to the Work Location Type in the job posting to see if this applies.
Apply now and make a lasting impact with the Amgen team.careers.amgen.comSalary Range97,109.10USD -131,382.90 USD
