Senior Device Engineer - Gaithersburg, Maryland
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We are focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
As a Sr. Device Engineer
in Gaithersburg, MD
, you will play a pivotal role in channeling our scientific and technical capabilities to make a positive impact on changing patients' lives.
As a Senior Device Engineer
your responsibilities are:
- 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.
- Lead complex device design transfer and scale-up projects as part of a combination product cross-functional team, to achieve targets in a timely fashion and to meet agreed upon quality standards, e.g. plan and review work to ensure that agreed objectives, timelines and budgets are met.
- 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).
- Maintain an awareness of the status of key technical challenges and opportunities in their area of expertise for the current combination product portfolio.
- 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
- Be a visible role model for technical and scientific leadership across Global Technical Operations in the field of manufacturing and lifecycle management of medical devices and combination products in the market place
- 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
- Typically will be expected to have a BS in Mechanical or biomedical engineering or related field
- Minimum of 5 years of technical experience in medical device/combination product development or operations role(s)
- Demonstrated experience developing and/or sustaining devices (Medical Devices and/or Combination products) within a pharmaceutical environment.
- A thorough understanding of the principles and concepts in relation to medical device development and lifecycle management. The role holder will be required to keep up to date with developments within the industry and understand how they may impact the function, e.g. regulatory guidelines
- A thorough understanding and experience in common medical device manufacturing methods, including but not limited to injection molding, automated assembly and principles of design for manufacturability
- Experience in development of risk based control strategies for medical device and combination product manufacturing
- The role requires project management and innovation skills, and a thorough understanding of design work and regulatory requirements, such as risk management, design controls, purchasing controls and design change.
- An in-depth knowledge of relevant compliance systems as appropriate to own function.
- Good knowledge of medical device and risk management regulatory requirements (e.g. ISO 13485, ISO 14971, CFR 820)
- Have a basic understanding of the overall drug or biologic development process from discovery through to launch.
- Have experience of technical supervision, coaching and mentoring or leading small matrixed teams of people or scientific projects.
- Evidence of strong communication skills and of building good relationships with cross functional team members and customers.
- Proficient experience in Microsoft Windows applications, CAD systems, Risk- and Change Management Tools and methodologies
- MS in Mechanical or biomedical engineering or related field
- Advantageous to have experience of preparing regulatory documentation (ideally in CTD format)
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.
A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca