Human Factors, Usability & User Technology Manager - R&D Devices

Biocon Biologics; Bengaluru; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Biocon Biologics Limited in Bengaluru, Karnataka seeks a Manager – Human Factors, Usability & User Technology Requirements to lead usability engineering for drug delivery systems, assess user interfaces, manage risk, and plan end-to-end usability testing.

You will establish internal capabilities, collaborate with patients, clinicians and KOLs, and translate insights into design inputs and technical requirements, ensuring compliance with global standards across the product lifecycle.

Qualifications

• 8-12 years total experience in human factors/usability engineering of medical devices (FDA Class II/III experience desired)
• Experience with HF methodologies: ethnographic research, user group interviews, contextual inquiries, focus groups, technical assessments, user interface evaluation, task analysis, hazard analysis & risk assessments
• Hands-on skills 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 and measurable engineering specifications
• Experience working with external service providers and certification agencies is preferred
• Experience in complete medical device product development lifecycle
• Strong understanding of medical device product design and regulatory processes
• Knowledge of ISO13485, EU MDD/MDR & US FDA 21 CFR Parts 4 & 820 and standards like IEC60601, ISO14971, IEC62366, ANSI/AAMI HE75
• Demonstrates integrity, collaboration, communication and change-driving capability
• Ability to work with entrepreneurial teams in a rapidly growing organization

Responsibilities

• Lead the Usability Engineering activities for drug delivery systems, including assessment of user interfaces, risk management, planning and execution of usability testing
• Establish internal capabilities and external relationships for HF & Usability engineering
• Lead Voice of Customer activities with patients, HCPs, KOLs to translate insights into requirements
• Translate user and KOL insights into actionable user needs, design inputs and technical requirements with cross-functional teams
• Ensure design, testing, documentation and regulatory filing meet HF and usability guidance and standards
• Collaborate with product engineering to identify intended users, use environments and hazards
• Determine product use cases, perform user task analyses, identify critical tasks and derive requirements
• Execute usability engineering deliverables across development life cycle phases
• Work with internal and external partners to plan, recruit for and execute formative and summative evaluations
• Collaborate with systems engineering teams to develop test plans and protocols for evaluation

Skills

Human Factors

Usability engineering

Regulatory understanding

User research

Formative & summative testing

Task analysis

Risk assessment

Stakeholder collaboration

Communication skills

Education

BE / MTech in Engineering

Job description

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 new 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
• 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.