Job Information
Mallinckrodt Pharmaceuticals Senior Human Factors Engineer in Dublin, Ireland
Job Title
Senior Human Factors Engineer
Requisition
JR000014857 Senior Human Factors Engineer (Open)
Location
Dublin, IRL
Additional Locations
Job Description Summary
The Senior Human Factors Engineer will be responsible for design validation of the company’s medical device products, ensuring that these products meet user needs. As part of cross-functional project teams, the role will lead and/or support human factors and design validation activities on complex medical devices over their complete lifecycle. This person needs to be a solutions-orientated team player and knowledgeable on organisation and execution of both formative and design summative validation studies and how to communicate the user feedback to the design team. The person needs to have a clear understanding of how ISO62366 and FDA guidance are integrated with ISO14971 and ISO13485.
Job Description
Develops an understanding of customer needs, customer processes, user groups and use environments to ensure relevant and innovative product development solutions.
Contributes to a culture of innovation by proactively generating novel solutions to improve product performance or enhance products' ability to address customer needs.
Designs and manages the execution of formative evaluation and contextual inquiry studies to inform device UI design while it is in development.
Designs and manages the execution of design validation studies:
Develops and uses best-in-class validation techniques applicable to the medical industry (e.g., human factors, clinical evaluation and training validation).
Optimises validation activities by grouping and ordering validation procedures in protocols. Defines high-level acceptance criteria and methods/techniques based on risk analysis and project objectives.
Defines and justifies study designs (e.g., appropriate sample size) to internal/external stakeholders. Plans and secures access to required units and test subjects.
Ensures validation and human factors activities comply with US / EU regulations and current medical industry standards.
Plans for validation execution within a hospital or simulated environment. Proposes partnerships with external hospitals or service providers (recruitment, proctoring, consulting etc.).
Manages and assesses external vendors/suppliers of validation services.
Plans acquisition and development of simulated use test setups.
Develops and maintains validation procedures to ensure successful integration of the medical device, IFU material, training and users. Develops a sustainable user needs coverage that fits well with other pieces of evidence generated by verification activities.
Works with cross-functional team to review study feedback, proposes solutions to ensure user needs are met and use-related risks are reduced by the final product.
Ensures data traceability, clarity and accuracy across all validation documents.
Clearly and accurately communicates with internal stakeholders (e.g., Clinical, Medical, Regulatory Affairs, Quality) and external stakeholders on validation progress and outcomes. Escalates issues as required.
Drives collaborative development with external partners to ensure technical requirements are achieved.
Supports regression analysis and provides impact assessment for change requests based on product knowledge and existing validation evidence. Prioritizes work through risk assessment.
Supports development of IFU and training material based on findings from formative evaluations.
Supports post approval regulatory submission for market expansion and timely technical responses to FDA and healthcare authority inquiries.
Writes and revises technical documents including SOPs, test protocols and reports.
Maintains usability file documentation for assigned projects (e.g., Use Specification, Task Analysis, Formative Evaluation Protocols and Reports).
Education / Experience / Skills:
MSc in Medical Device Design, or a MSc in Psychology
with 5+y experience on medical system design validation,
with 2+y experience with end users / patient in hospital environment.
Demonstrated evidence of medical device validation:
Over a complete product or project lifecycle (concept, development, qualification, submission),
In compliance with industry standards and regulations,
Using validation engineering techniques and clinical knowledge.
Demonstrated expertise in one or more of the following validation specialties: clinical evaluation, end user validation, usability studies or clinical trials
Excellent written and verbal communications skills to interface with multi-disciplinary teams and management.
Strong leadership to make rapid/clear decisions based on multi-disciplinary team recommendations.
Proven track record of successful test activities in a fast-paced environment.
Hands-on ability to perform testing.
Process- and detail-oriented.
Data driven.
Detailed understanding of IS013485, ISO62366, ISO14971 and FDA guidance on human factors and risk management.
• Willingness to travel frequently to execute and support off-site testing etc.
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Mallinckrodt provides equal employment opportunities to applicants and employees without regard to race; color; gender; gender identity; sexual orientation; religions practices and observances; national origin; pregnancy, childbirth, or related medical conditions; protected veteran status; disability; or any other category protected by law.
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