Reporting to the Directors, the position is located in Bristol, and is responsible for leading and growing a healthy, high-performing human factors team while delivering high-quality HF work for regulated medical devices and combination products. Success is measured by sustainable people leadership (retention, engagement, capability, compliance) and reliable delivery (quality, timeliness, client satisfaction), supported by sensible commercial stewardship.
Time allocation: ~50% Line Management / 50% HF Project Delivery (averaged per quarter)
Direct reports: ~6-10 HF engineers and consultants (i.e. all junior and middle-weight HF roles)
Responsibilities
* Plan resourcing; coordinate with project leads for project needs and contingency.
* Manage balance of billable and non-billable activities across the team.
* Identify opportunities to improve planning and resourcing processes alongside Operations Team.
* Lead weekly team resourcing meetings to ensure effective communication of team resourcing and workload planning.
* Work alongside Operations Team to provide input to analysis of data.
* Provide strategic input to Directors to inform recruitment needs to ensure appropriate team capacity.
Team Management & Engagement
* Perform structured 1:1s with documented actions for all direct reports.
* Define and manage career development plans for all direct reports; set clear competencies and progression milestones.
* Collaborate with senior leadership on team development to provide timely feedback and coordinate training.
* Maintain a skills matrix for HF competencies across the team.
* Ensure new starters are onboarded in a timely manner alongside Operations Team.
Quality & compliance
* Ensure mandatory QMS training is completed on time
* Support conduct of audits relevant to HF project delivery
* Carry out duties in compliance with established business policies, procedures and company brand guidelines.
* Produce and review project deliverables that are in compliance with applicable quality processes as per Rebus Medical QMS and ISO, FDA, and other regulatory agencies.
* Understanding of the medical device development process and how HFE can benefit at each stage of the process. Understand where design decisions are made and where Rebus need to be commercially sensitive with recommendations.
* Identify and apply current industry best practice and techniques.
* Where senior HF buffer resource is required to support resourcing:
o Manage the delivery of high-quality HF projects to clients, on time and on budget.
o Write and review study protocols, discussion guides and supporting documentation for formative and summative HF studies selecting appropriate research methods.
o Accurately analyze and synthesize large volumes of study data confidently and efficiently in accordance with study objectives (e.g. data manipulation in Excel)
o Accurately collect data through direct observation or post-hoc analysis of video.
o Impeccable data handling skills including accuracy of root cause data gathering during test sessions and accurate expert root cause analysis, trend identification and extrapolation of commercially sensitive recommendations.
o Author and review concise and accurate study reports in appropriate technical writing style whilst ensuring data integrity.
o Generate and review engaging and on-brand presentations using MS PowerPoint and Adobe CC Suite.
o Independently present and disseminate study results confidently to clients.
o Champion the application of good research practices such as taking informed consent, data privacy considerations and ethical best practices and demonstrate proactivity in keeping up to date with changes in applicable standards and best practices (e.g. BHBIA)
o Generate and review documentation of use-related risk assessments to help inform new device developments.
Consultancy Skills
* Work in a flexible and organized manner to support working across multiple projects running concurrently.
* Have a high degree of interpersonal and communication skills to work with cross-functional teams and audiences, including client teams.
* Work independently and as part of a team where required.
* Perform other duties and projects as assigned.
* Exhibit professional behavior with both internal/external business associates that reflects positively on the company and is consistent with the company’s policies and practices.
* Understand and maintain awareness of the quality consequences which may occur from the improper performance of their specific job.
* Contribute to the culture and ongoing development of the wider team skillset through knowledge sharing.
* Talk to client teams in their terms, listen to clients about their needs and issues and provide expert consultancy on all aspects of human factors in medical device development including regulatory advice and risk management.
* Create a friendly and open work culture for fellow employees where trust and communication are highly valued.
* Mentor and support the development of team members
Education / Experience / Skills
* Degree or higher in Human Factors Engineering, or relevant related subject.
* Applied understanding of the product development process.
* Applied understanding of medical device industry
* Relevant industrial experience commensurate with requirements of senior consultant
* Exceptional attention to detail and precise data handling and analytical skills.
* Technical report writing skills.
* Ability to travel when and where required.
* Exceptional time management skills and an ability to work well under pressure.
* Honesty and integrity with team members and client communication.
* Experience managing teams, fostering collaboration, and supporting professional growth.
* Excellent interpersonal and communication skills, with a proven ability to handle conflicts constructively and maintain a positive team environment.
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