Manager – Human Factors, Usability & User Technology Requirements

Role in a nutshell :

- Lead the Usability Engineering activities for drug delivery systems with direct responsibility of assessment of user interfaces, risk management, planning and overall execution of usability testing activities
- Establish internal capabilities and external relationships needed for all HF & Usability engineering needs of the organization.
- Lead Voice of Customer activities with patients, HCPs, KOLs and other intended users to identify unmet needs and translate user insights into requirements for current drug-delivery technologies and device concepts.
- Translate user and KOL insights into actionable user needs, design inputs and technical requirements, working closely with Device Engineering, Clinical, Medical and Commercial teams
- Ensure design, testing, documentation and regulatory filing requirements are fully compliant to all Human Factors and usability engineering related guidance and standards
- Collaborate with product engineering to identify intended users and use environments as well as potential use related hazards.
- Determine product use cases, carry out user task analyses, identify critical user tasks and assist in derivation of user requirements & technical specifications.
- Responsible for execution of usability engineering & HF deliverables for each development life cycle phase
- Collaborate with internal and external partners in planning, structuring, recruiting for, and execute formative and summative evaluations
- Work closely with different systems engineering & sub-systems team (mechanical & electronics) to understand overall system level architecture, user interface elements, identify critical safety and quality characteristics to develop usability test plan & protocols for execution

Qualifications:

- BE / MTech in Engineering or equivalent degree




- 8-12 years of total experience

Skills & Experience:

- Atleast 3 years of experience in Human Factors/Usability engineering of medical devices (FDA Class II/III medical device experience desired)
- Experience with various HF methodologies such as ethnographic research, user group interviews, contextual inquiries, focus group discussions, technical assessments, user interface evaluation, task analysis, hazard analysis & risk assessments.
- Hands-on skills with the proven ability to execute formative and summative testing of complex medical devices/systems
- Experience using user research to support early-stage technology assessment, concept development and device selection.
- Ability to translate qualitative user insights into user needs, design inputs, product requirements and measurable engineering specifications.
- Experience working with external service providers and certification agencies is preferred
- Required to have experience in complete medical device product development lifecycle
- Strong understanding of medical device product design and regulatory processes
- Working Knowledge & understanding of medical device regulations like ISO13485, EU MDD/MDR & US FDA 21 CFR Parts 4 & 820 & standards requirements like IEC60601, ISO14971, IEC62366, ANSI/AAMI HE75 etc...
- Possess a high level of integrity with a passion to work with entrepreneurial teams in a rapidly growing organization
- Strong collaboration, active listening & excellent written and verbal communication
- Strong presentation & documentation skills
- Ability to drive change in culture and behavior & demonstrate outstanding work ethic

We are an Equal Opportunity Employer committed to fostering a diverse, inclusive, and equitable workplace. We provide equal employment opportunities to all qualified applicants, regardless of background, identity, or personal characteristics.

📌 Human Factors, Usability & User Technology Manager - R&D Devices (Bengaluru)
🏢 BIOCON BIOLOGICS
📍 Bengaluru