Engineer I, Medical Device Design Control Documentation Specialist

Amgen • Cambridge, MA

290d • Hybrid

About The Position

At Amgen, if you feel like you're part of something bigger, it's because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we've helped pioneer the world of biotech in our fight against the world's toughest diseases. With our focus on four therapeutic areas -Oncology, Inflammation, General Medicine, and Rare Disease- we reach millions of patients each year. As a member of the Amgen team, you'll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Requirements

• High school diploma / GED and 8 years of Engineering experience; OR Associate's degree and 6 years of Engineering experience; Or Bachelor's degree and 2 years of Engineering experience; Or Master's degree.
• 5+ years of progressive experience as an engineer or scientist within the appropriate field of study.
• 3+ years of experience as a Subject Matter Expert within a development or research, manufacturing environment, working with Medical Devices, ideally Class II and Class III.
• Fluent in English language.
• Understands documentation flow for GMP deliverables.
• Solid experience in documentation authoring from project start to end, and under Design Controls.
• Technical understanding of drawings and manufacturing processes (injection molding, assembly processes).
• Experience in drug/device combination product design and development.
• Demonstrated experience with ISO and regulatory compliance process, Design History File.
• Creative problem solver and solution developer when presented with conflicting requirements, business demands and technical risks/issues.
• Experience in model-based design and UML and small-scale device assembly experience.
• Experience in leading system hazard analysis, risk evaluation, and FMECA.
• Deep knowledge of Quality Management System, Quality Management Policy and applicable laws and regulations.
• Familiar with US Good Manufacturing Practices - 21CFR820; Quality Management - ISO 13485; Risk Management - ISO 14971; EU Medical Device requirements - Council Directive 93/42/EEC.
• Strong background in documenting requirements and providing traceability documentation for FDA Approval.
• Practical experience in configuration management and change control process/requirements.

Nice To Haves

• Strong interpersonal skills.
• Strong communication and presentation skills.
• Ability to work within cross-cultural project teams.

Responsibilities

• Support device development and design control documentation.
• Accountable to complex, multi-disciplinary and cross-functional product development efforts.
• Manage interactions, dependencies, and interfaces across a full device development program.
• Ensure quality targets are satisfied and identify technical risks.
• Coordinate risk retirement activities on the program.
• Provide direction and support for all technical documentation.
• Drive and be accountable for DHF documentation.
• Own risk assessment integration between requirements, risks, and mitigation implementation.
• Provide oversight of the feedback loop from Design Input Requirements through Risk Assessments to the Design Outputs.
• Manage and maintain the traceability between risk and Requirements.
• Ensure compliance/closure of Regulatory and Quality requirements before approving Design Control Formal Design Reviews.
• Participate in project execution according to the Robust Design paradigm and principles.
• Utilize project planning and monitoring methods to ensure timely completion.
• Review and approve completed design work.

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.
• Flexible spending accounts.
• A discretionary annual bonus program.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree