Our client is a world class consultancy developing medical devices, combination products and point-of-care systems for a diverse client base which ranges from start-ups to large multinational organisations.
They are looking to appoint a Device Testing Manager to join our growing Device Testing group.
The role of the Device Testing function is to ensure we achieve the highest quality and integrity in testing medical devices from the early development stages through to industrialisation. The group supports our projects, adopting best testing practices while helping to find the right balance between bespoke and industry standard solutions.
The Device Testing group has a broad skill set and background of experience covering laboratory and equipment management, medical device development, device testing and statistical analysis.
Reporting to the Head of Device Testing, you will line manage our team of technicians, and work with project teams to plan and resource (permanent and contract people plus equipment and facilities) projects. You will work across a variety of projects from early-stage development through to formal design verification, ensuring that all test work is performed to the highest standard; also delivering test work for our clients. As an expert in device testing and technical lead, you will also regularly report and present your work and that of your team to clients.
Key responsibilities
· Line management and ongoing development of the group of technicians; ensuring continuous development of their skillsets and expertise
· Identify the key resources - equipment, people, and facilities required for the projects’ needs
· Proactively and collaboratively with the Head of Device Testing, drive improvements in device testing best practices
· Technical leadership in medical device development projects, in the field of device testing
· Delivery of high-quality device testing programmes to plan, across a variety of clients projects
· Lead technical investigations to identify root causes, and drive resolutions
· Write and review high quality, detailed technical documentation for both internal use and on behalf of the client
· Uphold health and safety procedures and guidelines to ensure save working with hazardous chemical and pharmaceutical formulations
Requirements
Qualifications and Skills
Essential
· Degree or equivalent experience in Science, Life Science or Mechanical Engineering
· Track record in technical leadership through planning, overseeing, and delivering a medical product testing programme
· Track record in developing and implementing complex or novel testing methodologies
· Proficiency in the use of data analysis tools including statistical methods.
· Application and understanding of key industry standards including ISO13485, 14971 and 21CFR Part 820
· Working knowledge of test method and equipment verification and validation best practices (e.g., Gauge R&R, IQ/OQ/PQ, FAT, SAT)
· Proficiency in working within a quality management system, following principles such as cGxP, ALCOA and data integrity
Desirable
· Experience of using Minitab statistical software
· Experience supporting sales activities including proposal preparation, evaluation of project risks, project planning and costing
· Detailed understanding of one of the following markets:
· Drug delivery (injectables, inhalation, or drug packaging)
· Surgical / critical care
· Diagnostic instrumentation
Leadership / Consultancy Skills
Essential
· Experience of managing, mentoring and developing people in a matrix organisation
· Excellent organisational skills and able to prioritise conflicting requirements
· Structured and methodical problem-solving abilities
· Clear, concise communication and presentation skills to technical and non-technical audiences, including clients
· Ability to collaborate effectively with colleagues, clients and sub-contractors at all levels
Desirable
· Experience of working in a consulting, or other fast paced, environment
· Able to effectively collaborate and improve best practices by proactively reviewing and challenging current practices
Personal Qualities
· Passionate about and committed to driving excellence and best practice in own discipline; demonstrable track record of continuous learning, knowledge sharing and of nurturing the talents of others
· Has a positive and engaging communication style
· Inspires confidence and gains the trust of clients and colleagues through personal style and professional/technical credibility
· Respectful of others’ views, opinions and contributions, and supportive of colleagues
· Collaborates effectively and is a good team player, including being aware of own limitations and of the strengths of others
· Excellent attention to detail
· Decisive, adaptable and pragmatic
· Resilient and calm under pressure
· Shows integrity and honesty at all times
Additional Role Requirement and Working Patterns
· Predominantly working onsite