Sr. Engineer, Design Assurance, Risk Management, Human Factors Engineering

3 days ago

Dublin, Dublin City, Ireland Emergent BioSolutions Full time
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Sr. Engineer, Design Assurance, Risk Management, Human Factors Engineering

Location:

Dublin, IE

We go where others won't, taking on some of the biggest public health challenges to protect and enhance millions of lives, and create a better, more secure world. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed to protect and enhance life.

I. JOB SUMMARY

The Senior Engineer, Design Assurance & HF Eng, with minimal oversight, will be responsible for the development, compilation and maintenance of the design history files, including risk management files and human factors engineering files of Emergent Medical Device and Combination Product programs during development, transfer to commercial, and commercial lifecycle management phases of the product lifecycle.

The position will be responsible for ensuring the compliance of design control, including risk management and human factors engineering activities, with international standards, regulations, and the company's QMS. The position will report to the Director, Design Assurance & Human Factors Engineering.

II. ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

1. Oversee and manage the design history file, ensuring that the files contained within are phase appropriate for the stage of development.
2. Manage and contribute to risk management documents, activities, and reviews, ensuring phase appropriateness for the stage of development.
3. Manage, contribute to, and execute on human factors engineering strategy, documents, activities, and reviews, ensuring phase appropriateness for the stage of development.
4. Support the design transfer of medical device and combination products.
5. Prepare technical documentation in accordance with the design control and regulatory requirements in line with the company's development processes.
6. Coordinate and assist in the preparation of the technical documentation, including determining the agenda, needed for design review meetings at appropriate phases in development and generate the design review minutes and/or report. Chair design review meetings when required.
7. Oversee and coordinate the design changes within the product development team and product team, ensuring proposed changes are appropriately assessed from a technical and risk perspective and implemented according to design control principles and company processes.
8. Oversee and coordinate technical assessment and evaluation of product deviations, investigations, complaints etc.
9. With minimal oversight, generate departmental, site and global standard operating procedures, work instructions and training associated with design and development for Combination Products and Medical Devices.
10. Provide peer review and technical inputs on the key regulatory submission documents, e.g., NDA, FDA Type C, EMA scientific advisory.
11. Provide support to technical team during regulatory and notified body inspections.
12. Write study protocols, technical reports and SOPs.
13. Execute responsibilities in compliance with ISO 13485 Design Control and ISO 14971 Risk Management for Medical Devices, relevant human factors guidance documents and standards as well as applicable ICH Guidelines for Pharmaceutical Development and Emergent Standard Operating Procedures.
14. Responsible for identifying defects and having the authority to report device defects at any time.

BEHAVIORS:

To perform the job successfully, the individual should demonstrate the following competencies:

1. Leadership – Through attitude and personal actions, inspire and motivate others to perform well; Effectively influences actions and opinions of others; Inspires respect and trust; Accepts feedback from others; Gives appropriate recognition to others.
2. Problem Solving – Identifies and resolves problems in a timely manner, analysing information skilfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
3. Interpersonal – Focuses on solving conflict, not blaming; Maintains confidentiality; Listens to others without interrupting; Keeps emotions under control; Remains open

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