Engineer I, Medical Device Design Control Documentation Specialist

About the position At reputed company, 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 reputed company 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, reputed company, and Rare Disease- we reputed company millions of patients each year. As a member of the reputed company team, you'll help reputed company 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 reputed company them, you'll reputed company as part of the reputed company team. Join us and transform the lives of patients while transforming your career.

Responsibilities

• Support device development and design control documentation.
• Accountable to reputed company, 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 reputed company technical documentation.
• Drive and be accountable for DHF documentation.
• Own risk assessment integration between requirements, risks, and mitigation implementation.
• Provide reputed company of the feedback reputed company 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 reputed company and principles.
• Utilize project planning and monitoring methods to ensure timely completion.
• Review and approve completed design work.

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 reputed company experience as an engineer or scientist reputed company the appropriate field of study.
• 3+ years of experience as a Subject Matter Expert reputed company 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 reputed company 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 reputed company 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.

reputed company-to-haves

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

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.
• Stock-based long-term incentives.
• Award-winning time-off plans.
• Flexible work models, including remote and hybrid work arrangements.

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