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

Job title:

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

Company

Emergent BioSolutions

Job description

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

• Oversee and manage the design history file, ensuring that the files contained within are phase appropriate for the stage of development.
• Manage and contribute to risk management documents, activities, and reviews, ensuring phase appropriateness for the stage of development.
• Manage, contribute to, and execute on human factors engineering strategy, documents, activities, and reviews, ensuring phase appropriateness for the stage of development.
• Support the design transfer of medical device and combination products.
• Prepare technical documentation in accordance with the design control and regulatory requirements in line with the company’s development processes.
• 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.
• 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.
• Oversee and coordinate technical assessment and evaluation of product deviations, investigations, complaints etc.
• 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.
• Provide peer review and technical inputs on the key regulatory submission documents, e.g., NDA, FDA Type C, EMA scientific advisory.
• Provide support to technical team during regulatory and notified body inspections.
• Write study protocols, technical reports and SOPs.
• 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.
• 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:

• 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.
• Problem Solving – Identifies and resolves problems in a timely manner, analysing information skilfully; Develops alternative solutions; Uses reason even when dealing with emotional topics.
• Interpersonal – Focuses on solving conflict, not blaming; Maintains confidentially; Listens to others without interrupting; Keeps emotions under control; Remains open to others’ ideas and tries new things; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; follows through on commitments.
• Teamwork – Contributes to building a positive team spirit; Puts success of team above own interests; contributes to morale and group commitments to goals and objectives.
• Business Acumen and Ownership – Understands implications of decisions. Works within approved budget. Where opportunities present, will develop, and implement cost saving measures. Conserves organizational resources.

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management’s assignment of essential functions.III. MINIMUM EDUCATION, EXPERIENCE, SKILLS

• Bachelor’s degree in the field of Pharmacy, Pharmaceutical Sciences, Mechanical Engineering, Biomedical Engineering, (or similar disciplines). Master’s degree or PhD preferred.
• Minimum 5+ years of experience in pharmaceutical development and/or medical device development. 7+ years is preferred. Direct experience in drug-device combination product research and development is desired.
• Direct experience of generating and managing design control documentation as per the requirements of FDA 21 CFR Parts 4 and 820, including FDA QMSR Final Rule dated 02Feb2024 and ISO 13485 Design Control is essential.
• Thorough understanding of the application ISO 14971 Risk Management for Medical Devices to product development is essential.
• Thorough understanding in the application of IEC 62366, FDA Human Factors Engineering Guidance and HE75 guidance to product development is desired.
• Thorough understanding of industry standards, FDA guidance, quality systems, verification, validation, design transfer, and quality engineering principles for medical devices and combination products is desired.
• Knowledge and experience in using requirements and change management software e.g. Trackwise, Veeva, JAMA etc. is essential.
• Experience in the design, development and qualification of a broad range of pharmaceutical drug-device combination products such as: pre-filled syringes, autoinjectors, long acting injectables, nasal sprays and implantable dosage forms is desired.
• Knowledge of quality by design principles and application of ICH principles to pharmaceutical development is desired.
• Thorough understanding of generating documentation for CMC for regulatory filings for pharmaceutical products is desired.
• Experience with the creation and maintenance of failure modes effects analysis (FMEA) is desired.
• Experience with Design of Experiments (DOE) and statistical analysis is desired.
• Proven ability to work independently and/or in a cross-functional, cross-cultural, and different time-zones in a virtual/remote environment.
• Strong communication skills and ability to drive cross-functional decision making.
• Proven ability to influence with and/or without authority.
• Strong critical thinking skills required to judiciously plan and prioritize project activities.
• Strong and consistent commitment to quality.
• Ability to integrate feedback in a professional manner.
• Ability to mentor technical and non-technical staff is desired.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.Reasonable accommodations may be made to enable individuals with disabilities to perform all essential functions.Emergent BioSolutions is an Equal Opportunity/Affirmative Action Employer and values the diversity of our workforce. Emergent does not discriminate on the basis of race, color, creed, religion, sex or gender (including pregnancy, childbirth, and related medical conditions), gender identity or gender expression (including transgender status), sexual orientation, age, national origin, ancestry, citizenship status, marital status, physical or mental disability, military service or veteran status, genetic information or any other characteristics protected by applicable federal, state or local law.Per CDC guidelines, Emergent strongly recommends that all employees working on site are vaccinated to help ensure their safety, as well as the safety of fellow employees. This includes the use of good judgment when determining when the CDC guidelines advise that you stay home when ill.Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our .Emergent BioSolutions does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on Emergent BioSolutions’ approved agency list. Unsolicited resumes or candidate information submitted to Emergent BioSolutions by search/recruiting agencies not already on Emergent BioSolutions’ approved agency list shall become the property of Emergent BioSolutions and if the candidate is subsequently hired by Emergent BioSolutions, Emergent BioSolutions shall not owe any fee to the submitting agency.

Expected salary

Location

Dublin

Job date

Sat, 15 Mar 2025 23:36:35 GMT

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