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’re 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 the Principal Device Engineer in West Chester, OH, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives.
As the Principal Device Engineer, you will provide technical quality leadership and support for West Chester medical device and combination products. This role will partner with internal and external partners for product development efforts to ensure product design history and risk management files are in accordance with FDA 21 CFR requirements and international standards.
The Principal Device Engineer will be responsible to lead quality planning and risk management activities, as well as to provide sustaining engineering support through post-market surveillance, design changes, etc.
The Principal Device Engineer will be the Device Site Champion and will lead efforts at the site to transform West Chester into a Center of Excellence in Combination Products and Medical Devices.
• Lead medical device and combination product Quality System initiatives at West Chester. Develop strategies, priorities, and plans as required.
• Support activities related to the Combination Product and Medical Device Quality Management System ensuring compliance to all applicable regulations.
• Authoring, compilation and maintenance of Design History File content, Conformity Assessments, and Design Verification Plans
• Author technical specifications, design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Reviews, Design Verification, Design Validation, and Design Transfer)
• Support actions required as a result of updates to standards and/or new applicable standards.
• Verification Plans and DHF creation/maintenance (including DMR), conformity assessments and risk management documentation
• Manage projects related to compliance of the quality system, development of new procedures and controls, and maintenance of established programs.
• Provide quality engineering support for the handling and trending of device design related complaint records.
• Provide quality guidance in the handling of nonconformance and CAPAs related to the medical device development process.
• Provide quality and technical support for the evaluation of change assessments for the combination product Quality system.
• Interface with suppliers to address development, risk management, change control, quality or auditing activities.
• Work cross-functionally to provide product quality requirements and quality standards into design inputs, to develop product specifications, and to conduct design verification and validation activities.
• Develop risk-based sampling plans for design verification and validation testing. Lead risk management and quality planning activities.
• Lead design control gap assessments, remediation planning, and remediation execution as required.
• Support the New Product Introduction (e.g. Prefilled Syringes, Auto injectors, etc).
• BS and/or MS in engineering or equivalent technical discipline
• Five (5) years or more of experience supporting Quality Engineering of Combination Products and Devices
• Extensive knowledge of global Quality System requirements (specifically 21 CFR Parts 4, 210, 211, 803, 806, & 820, and ISO 13485) required
• Extensive knowledge of both US and International Design Control and Risk Management requirements (specifically 21 CFR Part 820.30, ISO 13485, ISO 14971, Medical Device Directive 93/42/EEC), as well as other applicable standards required
• Experience with Health Authority interactions
• Ability to lead efforts at the site and influences the regional and global Quality organization to create policy, provide guidance and influence senior Leaders in the area of GMP Device and Combination Product compliance.
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.