Associate Director, Drug Delivery and Device Development
Posted on Apr 5, 2021 by Alexion Pharmaceuticals
This position will serve the role of Associate Director for Device Engineering of Alexion products including continuous product improvement within Global Product Development function of Alexion. The candidate will drive the technical aspects of device engineering for product development as well as lifecycle management. The candidate will manage device engineering subgroup within drug delivery and device development function. that covers design, design verification testing and industrialization activities for pipeline products. This position will interface with device partners and interact with multiple Alexion functional teams including Clinical, Manufacturing, Marketing, Purchasing, Quality, Regulatory, and Supply Chain, from clinical development through registration and commercial support. This will be a remote position.
Manage the subteam of device engineering that covers design, design verification testing and industrialization to support integrated design control activities from clinical development through registration and commercial support.
Work with device partner in the creation, evolution, optimization and verification of designs and hardware for drug delivery devices, their associated test equipment precision measurement systems and other such equipment.
Evaluate designs for function, assembly, manufacturability, etc. using both CAE and traditional Engineering techniques.
Oversee mechanical or electromechanical systems on bench top models, during design development and verification.
Develop internal and external capability of design verification testing.
Drive the technology transfer efforts for new combination products into internal and external manufacturing on fill -finish, drug delivery device scale-up from development to commercial scale industrialization through tooling and assembly processes.
Manage development as well as life cycle management for medical device with Embedded SW or SW as a medical device including oversight of partners' activities and deliverables
Communicate effectively, both verbally and in writing, internally across departments and with external suppliers.
Ensure all designs function as required and comply with the Company's quality assurance requirements as well as applicable regulatory requirements.
Experience of commercialization of mechanical or electro-mechanical injection systems or similar drug delivery presentation.
Working experience in phase based design control activities with integrated risk management deliverables and human factors/usability engineering studies, from research through registration, launch and life cycle management.
Tracking record in development and lifecycle management of Medical Device with Embedded SW or SW as a Medical Device
Execution of new product introduction, design and development of extruded, molded and/or assembled medical device and combination products.
Good understanding of mold and fixture design and build as well as application of validation processes (IQ/OQ/PQ) in combination product device manufacturing.
Demonstrated ability to facilitate the interface between the pharmaceutical company and the medical device vendor base
Strong communication, collaboration and team building skills; ability to connect with all levels of the organization. Proficient in writing internal reports, project summaries, and internal/external presentations
Deep knowledge of the performance, safety and regulatory compliance (EU and FDA) requirements of medical device and combination products (eg ISO 11608 series, ISO 14971, IEC 60601 series, IEC 62304, FDA QSR 21 CFR Part 4 and 820/ISO13485 quality system requirements, and related FDA guidance).
Bachelor, Master's or PhD Degree in Engineering (Electrical Engineering, Biomedical, Mechanical, or Chemical) plus 12-18 year experience (8-12 year for PhD) in medical device development with 7+ years in combination product commercialization.