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Gaithersburg, Maryland, United States
Job reference: R-047651
Posted date: May. 06, 2019

AtAstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

As the Senior Device Engineer within Global Technical Operations you will be accountable for commercial device technology and maintaining Design History File for commercial devices and combination products.  The position is a corporate global role, to be based in Gaithersburg, Maryland.  The person will work closely with device development group to ensure smooth and seamless design transfer for combination product pipeline projects. 

Main Responsibilities:

  • Receive Design History File (DHF) from development and responsible for life cycle management of this DHF across manufacturing sites.
  • To lead complex Combination Product/device design transfers, technical commercial scale-up, process validation and lifecycle management aspects of medical devices / combination products
  • To proactively provide expert technical and scientific contributions from a manufacturing operations point of view, which impacts and influences the development of combination products and medical devices.
  • To provide indirect scientific or technical guidance and leadership to Engineers and Technicians to enable them to optimally meet their project objectives.
  • The role requires strong technical skills alongside project management, influential and innovation skills, and a thorough understanding of design controls, change- and risk management principles and regulatory requirements for combination products and medical devices. 
  • Management of continuous improvement projects, design changes and lifecycle management of on market medical devices and combination products, including but not limited to leading impact assessments and action plans.
  • Ensure that work is performed in accordance with appropriate quality and compliance standards, e.g. QSR/ISO/MDD/GMP/GLP and SHE requirements. 
  • Represent the technical operations function on medical device and combination product  cross-functional development teams, ensuring the provision of appropriate data (technical, resource & budgetary).
  • Develop and maintain a level of knowledge and competence, including specialist expertise in a Device manufacturing technologies, design for manufacturability and assembly operations.
  • Ensure effective transition and manufacturing scale up of combination products and medical devices to operations.
  • Create and maintain control strategies, use, design and risk management documentation
  • Work collaboratively with peers across several functions to build technical communities and collaboration.
  • Be recognized internally and externally as an expert in their specialist area
  • Be recognized and in demand as a problem solver for key technical challenges in their area of expertise
  • Demonstrate creativity and innovation to implement new methods, products, technologies or ways of working in area of expertise

Minimum Requirements:

  • MS in Mechanical or biomedical engineering or related engineering/ scientific field
  • Advantageous to have experience of preparing regulatory documentation (ideally in CTD format) 
  • Greater than 7 years’ experience in drug product/ parenteral and/or biotech/pharmaceutical company
  • Extensive technical knowledge of commercial devices  technology (greater than 5 years direct experience with drug product development, manufacturing or commercialization)
  • Experience supporting commercial biological combination product is a plus
  • Broad based understanding of drug development process from late stage development through commercial life-cycle management.
  • Experience working with cGMP and supporting regulatory inspections is a plus
  • Excellent communications skills with the ability to work effectively in cross functional teams and effectively influence team members. Establish effective relationships with stakeholders.
  • Ability to work in a complex, dynamic, global environment and willingness to travel when necessary.
  • Innovative problem-solving skills
  • Strong technical writer
  • Statistical analysis experience

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law

Senior Device Engineer - Operations
Global Operations

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