Associate Director, Human Factors Engineering

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At Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science.In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

This newly created position will play a leadership role in developing and steering the growing BMS HFE program.

Specific responsibilities include:
  • Creating HFE plans for device development programs ensuring that the resulting HFE data package fulfils the regulatory expectations for design validation per 21 CFR 820 and ISO 13485.
  • Planning and execution of Human Factors Studies (HFS) in accordance with FDA guidance and national and international standards (esp. IEC 62366).
  • Embedding, standardizing and improving HFE processes, procedures and workflows into the broader Design Control, Risk Management and QMS processes and procedures
  • Maintaining current awareness in the state-of-the-art in HFE.
  • Leading a small team of HFE engineers.
  • Acting as a subject matter expert for HFE internally and in health authority interactions.
  • Contributing to the HFE, risk management and design validation components of the Design History File and regulatory submissions.
  • Scouting, evaluation and introduction of new technologies and instrumentation into HFS workflows.
  • Collaboration with sourcing and procurement teams to develop and maintain HFE service provider base to enable development of agile HFE plans and HFS.
  • Close cross-functional collaboration across the enterprise to ensure HFE considerations taken into account across all phases of the development process.
  • Vendor and contract management with HFE vendors, including compliance to regulations and internal procedures.
  • Promotion of an empowered innovation culture and enterprise mindset within Device Development which facilitates a risk-balanced approach to product development.


QUALIFICATIONS

BS degree in Industrial Design, Engineering or other relevant discipline. Advanced degree desirable.

Minimum of 10 years of Human Factors or Usability Engineering experience in a product development environment with a strong track record of achievement. Experience in the Medical Device, Pharmaceutical or other regulated healthcare industry is desirable. Direct experience of drug/device combination product development, drug delivery devices and injection technologies a plus.

Knowledge and experience of the Quality System Regulation (21 CFR 820), combination product regulations (21 CFR part 4), EU MDR and medicinal product directives and FDA human factors guidance, and the application of ISO 13485, ISO 14971, IEC 62366 and other appropriate standards is highly desirable.

Formal training or significant experience in ergonomics, behavioral sciences, biomechanics, qualitative/quantitative and UI/UX research highly desirable.

Strong technical skills, and understanding of delivery devices, customers, market and the competitive environment.

Strong negotiation, influencing and communication skills.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

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