Human Factors Regulatory Consultant

4 weeks ago

Cambridge, United Kingdom Sagentia Full time

Sagentia Innovation provides independent advisory and leading-edge product development services focused on science and technology initiatives. We work across the medical, industrial, chemicals and energy, food and beverage, and consumer sectors, and with a broad range of companies from some of the world’s leading and best-known brands, to start-up disruptors new to the market. Our breadth of expertise brings together the best people to solve a problem and can include our scientists, engineers, human factors experts, data and AI scientists, innovation strategists, product developers and designers, and consumer insight specialists.

The opportunity
To support Sagentia Innovation’s increasing Human factors compliance offering within our Medical Sector, we are recruiting a Human Factors Regulatory Consultant to join our world class team of product developers and R&D strategists. Working with our Head of Human Factors (HF), this role will give you the opportunity to support and develop HF/Usability Engineering Files and use-related risk documentation, ensuring best practice and consulting directly with our clients on key HF projects.
Success in the role will require collaboration with multidisciplinary medical device development teams in Sagentia Innovation, as well as collaboration with our client’s project teams

We have:
• A multitude of exciting medical, diagnostic and combination device projects for you to engage in the HF activities, implementation and project documentation.
• Experienced applied science, engineering, and embedded software teams to help collaborate with from insight generation to summative study and regulatory submission.
• An extensive advisory team delivering strategic visions and roadmaps requiring a human centered approach.

You will have:
• Proven experience working in a HF function guiding pragmatic activities and documenting outputs in accordance with FDA human factors guidelines, MDR, IEC:62366 and HE 75 regulatory requirements. These include:
• Creation of use specifications, user interface specifications and user interface evaluation plans, workflow assessment and task analysis
• Hazard and risk related documentation and traceability including uFMEA/UERAs
• Experience of Medical device project quality management in a project-based organisation.
• Knowledge of ISO 13485, FDA QSR and Medical Device Directive (MDD)/Medical Device Regulations (MDR) to support additional quality engineering functions.
• A Degree level qualification in a relevant engineering, design or science discipline.

You might also have (but not essential):
• Experience in the recruitment, leading and documentation of Voice of Customer, Formative and Summative engineering studies.
• Previous background in a product design function.
• Knowledge of generating technical publications, such as accompanying documentation and training materials
• Worked in a client facing consulting environment.

Career development
We offer bespoke training and mentoring to allow you to thrive within our environment and fully realize your personal goals and potential. You will have the opportunity to develop:
• QMS continuous improvements and be involved in internal projects relating to the implementation of new tools that may enhance our HF function
• Business development expertise by providing pre-sales input and assistance, interfacing directly with clients under the guidance of our business development team.
• Strong interpersonal and communication skills, to gain the confidence and capability required in a client facing role.

Benefits
You will be offered a competitive salary and benefits package.

  • Human Factors Engineer

    9 hours ago

    Cambridge, United Kingdom Cubiq Recruitment Full time

    Human Factors Engineer Location: Cambridgeshire Job Type: Permanent Salary: £60,000 DOE Industry: Regulated Product Design   What we can offer you Above-statutory Pension Scheme and Holiday Entitlement, Private Health Plan for you and your Family, Bonus Scheme, Hybrid Working About the opportunity My client are a market leader in the Design...

  • Human Factors Engineer

    2 weeks ago

    Cambridge, United Kingdom Morson Talent Full time

    Company overview:Submit your CV and any additional required information after you have read this description by clicking on the application button.Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational...

  • Human Factors Engineer

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Morson Talent Full time

    Company overview: Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems. Role: The role of Senior Human Factors Engineer is a great opportunity...

  • Human Factors Engineer

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Morson Talent Full time

    Company overview: Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems. Role: The role of Senior Human Factors Engineer is a great opportunity...

  • Human Factors Engineer

    1 month ago

    Cambridge, Cambridgeshire, United Kingdom Morson Talent Full time

    Company overview: Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems. Role: The role of Senior Human Factors Engineer is a great...

  • Human Factors Lead

    1 month ago

    Cambridge, United Kingdom Cambridge University Hospitals Full time

    **Main area** - Corporate - Human Factors Lead**Grade** - Band 8a**Contract** - Permanent**Hours** - Full time - 37.5 hours per week (Flexible Working Considered)**Job ref** - 180-F-245053-RE**Employer** - Cambridge University Hospitals NHS Foundation Trust**Employer type** - NHS**Site** - Addenbrookes Hospital-Division Corporate**Town** -...

  • Human Factors Engineer

    1 month ago

    Cambridge, United Kingdom CareerBliss Full time

    Company overview:Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems.Role:The role of Senior Human Factors Engineer is a great opportunity to...

  • Human Factors Engineer

    4 days ago

    Cambridge, United Kingdom Morson Talent Remote Work Freelance Full time

    Company overview:Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems.Role:The role of Senior Human Factors Engineer is a great opportunity to...

  • Human Factors Engineer

    3 weeks ago

    Cambridge, United Kingdom Morson Talent Full time

    Company overview:Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational...

  • Human Factors Engineer

    4 weeks ago

    Cambridge, United Kingdom Morson Talent Full time

    Company overview:Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems.Role:The role of Senior Human Factors Engineer is a great opportunity to...

  • Human Factors Engineer

    4 weeks ago

    Cambridge, United Kingdom Morson Talent Full time

    Company overview:Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems.Role:The role of Senior Human Factors Engineer is a great opportunity to...

  • Human Factors Engineer

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Morson Talent Full time

    Company overview: Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational infrastructure, special product infrastructure and mission systems. Role: The role of Senior Human Factors Engineer is a great...

  • Human Factors Engineer

    3 weeks ago

    Cambridge, Cambridgeshire, United Kingdom Morson Talent Full time

    Company overview: Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding. Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational...

  • Human Factors Engineer

    1 month ago

    Cambridge, United Kingdom The One Group Full time

    If you are a Human Factors Engineer with 2+ years' industrial experience and can offer some seriously impressive skills in an R&D environment, we would like to hear from you. The ONE Group are working with a range of Cambridge based consultancies and organisations who are looking for people like you. You will need to have experience in medical devices and be...

  • Human Factors Engineer

    3 weeks ago

    Cambridge, East Anglia, United Kingdom Morson Talent Full time

    Company overview:Are you ready to apply Make sure you understand all the responsibilities and tasks associated with this role before proceeding.Our client designs, develops, manufactures, tests and supports deployable solutions to provide rapid deployments of military and civilian capability to operations worldwide. This ranges from operational...

  • Human Factors Specialist

    1 month ago

    Cambridge, United Kingdom Underwriters Laboratories Inc. Full time

    : At UL, we know why we come to work.: Thousands of us around the world wake up every day with a common purpose: to make the world a safer, more secure and sustainable place. Science is in our DNA; we are endlessly curious and passionate about seeking and speaking the truth. We take delight in knowing that our work makes a meaningful contribution to society,...

  • Human Factors Associate

    4 weeks ago

    Cambridge, United Kingdom Cambridge Design Full time

    **About The Role**: Cambridge Design Partnership is a leading technology and product design consultancy, managing and delivering global project work for innovative consumer and healthcare companies. A unique, dynamic and innovative consultancy based in Cambridge you’ll work alongside our cross-disciplinary user centred design team. In this client facing...

  • Human Factors Design Engineer

    3 days ago

    Cambridge, Cambridgeshire, United Kingdom Newton Colmore Consulting Full time

    Human Factors Design Engineer - Medical Devices - Cambridge A Medical Devices company, based in Cambridgeshire, is currently looking for a Human Factors Design Engineer to assist with the ongoing development of new Medical Devices. Working alongside an established R&D team, your role will be of paramount importance in ensuring that product design...

  • Electronics Engineer Consultant

    2 days ago

    Cambridge, United Kingdom Newton Colmore Full time

    Electronics Engineer Consultant - Security Clearance - CambridgeA new design consultancy, based in Cambridge, are currently looking for a Electronics Engineer Consultant to add to the team of experienced experts, specifically with a focus on security cleared projects.Although this is a new design consultancy, they have the backing of larger companies meaning...

  • Electronics Engineer Consultant

    3 days ago

    Cambridge, United Kingdom Newton Colmore Full time

    Electronics Engineer Consultant - Security Clearance - Cambridge A new design consultancy, based in Cambridge, are currently looking for a Electronics Engineer Consultant to add to the team of experienced experts, specifically with a focus on security cleared projects. Although this is a new design consultancy, they have the backing of larger companies...