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CSL · 6 days ago

Senior Engineer (Drug Delivery Lead)

Americas, US-MA, Waltham, CSL Behring

Full-time

Onsite

Senior Level

7+ years exp

CSL is a global biotherapeutics company that develops combination products and medical devices for drug delivery systems. The Senior Engineer will be responsible for bringing new Drug Delivery Systems through the development process, collaborating with cross-functional teams, and ensuring compliance with regulatory standards.

BiotechnologyHealth CareHealth DiagnosticsMedical

Comp. & Benefits

Responsibilities

Responsible for the planning and execution of projects for evaluation, selection, improvement, and implementation of new or existing primary packaging materials, medical devices, and Combination Products for CSL products

Execution of projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices

Collaborate with global internal cross-functional expert teams. Provide leadership to ensure the coordination of activities and information between the functions and with external partners

Application of expertise in Design Controls and Risk Management (ISO 13485, ISO 14971, and 21 CFR 820), EU MDR requirements, compilation and maintenance of Design History Files, design verification and validation, and clinical trial/commercial manufacture support

Provide leadership to Project Team to deliver submission-ready packages for Notified Bodies and regulators, as well as RFI responses

Utilise engineering and analysis tools to ensure robust designs and understand device limitations, (e.g., root cause analysis, tolerance analysis, probabilistic design)

Qualification

Drug Delivery SystemsDesign ControlsRisk ManagementBiomedical EngineeringRegulatory StandardsProject LeadershipCommunication SkillsOrganizational Skills

Required

University level education; ideally a Masters or PhD in Biomedical Engineering, Electrical or Mechanical Engineering or in a related field

Minimum of 7 years in drug delivery device development with relevant pharma industry experience or other highly regulated environment

Proven ability to work closely and efficiently with employees and colleagues of all levels as well as proven ability to be independent and self-motivated, demonstrating strong organizational and communication skills (English)

Experience with regulatory and quality standards and generation of documentation to support quality assessments and for submission to regulatory agencies