Description

Senior Human Factors Engineer with 5+ years of experience helping MedTech companies design intuitive, safe, and compliant medical devices. I bring deep expertise in usability engineering per IEC 62366-1, risk management aligned with ISO 14971, and regulatory compliance with EU MDR.

I support the full HFE lifecycle—from Use Specification and Task Analysis to Use-Related Risk Analysis (URRA), formative studies, and summative usability validation—ensuring identification and mitigation of critical tasks and use errors. I integrate Human Factors into design controls, labeling (IFU/QRG), and verification/validation activities to meet FDA and EU expectations.

Additionally, I drive post-market usability activities, including Known Problem Analysis (KPA), complaint trending, and proactive risk identification using sources such as MAUDE and vigilance databases.

Industry field of expertise

Languages

English
Native or bilingual
Hindi
Native or bilingual
Danish
Conversational

Workplace preferences

Remote only

Primarily works remotely

Becton Dickinson
Senior Human Factors Engineer
October 2025 - Today (8 months)
Limerick, Ireland
• ● Lead Human Factors for MDR compliance on BD's infusion-pump platforms, defining usability engineering strategy aligned with EU MDR, IEC 62366-1, ISO 14971, and BD internal Quality System requirements.
• ● Develop and execute UOUP (User Interface of Unknown Provenance) strategy, including retrospective usability justification, evidence gap analysis, and creation of MDR-compliant documentation for legacy interfaces
• ● Design, lead, and report Summative (Human Factors Validation) Studies, including protocol development, risk alignment, participant segmentation, data synthesis, and regulatory-ready justification for safety and effectiveness.
• ● Drive cross-functional alignment with Systems, Risk Management, Clinical, and Regulatory teams to ensure usability risks are identified early and mitigated throughout the product lifecycle.
• ● Deliver Human Factors training and capability building across engineering, design, and quality teams — establishing shared understanding of HFE principles, regulatory expectations, and best-practice documentation.
• ● Support and shape BD's long-term HFE regulatory strategy for future infusion device development, including harmonization of formative/summative approaches, URRA frameworks, and evidence requirements for global submissions (MDR, FDA)
• ● Champion integration of usability engineering into early design controls, ensuring robust traceability from user needs → hazards → mitigations → design requirements → validation.
Human factors Usability engineering
Phillips-Medisize, Molex- Company
Human Factors Engineer II & Post-Market Surveillance
February 2024 - February 2026 (2 years)
2830 Virum, Denmark
• ● Owned and executed end-to-end HFE responsibilities, including use specification, cafeteria testing, usability risk assessment, and risk integration, ensuring regulatory compliance and user safety across medical device programs, such as drug delivery systems/platforms, among other*.
• ● Led the development of usability engineering strategy from initial research and conceptualization through proof of concept and final design specifications for a pediatric pre-filled syringe intended for treating severe hypoglycemia in infants ages 0-2 years.
• ● Innovated HFE and ergonomic guidelines, including force requirement data, to support mechanical and systems engineers in designing safe, intuitive injection devices like pre-filled syringes and auto injectors.
• ● Promoted cross- functional teamwork by aligning HFE with engineering, clinical and regulatory teams to ensure integrated, user-centered development of medical devices.
• ● Collaborated cross functional to ensure alignment between design specifications, manufacturing requirements and regulatory standards, ensuring a seamless transition from design to production.
• ● Established and managed a known problem analysis database specific to auto injectors and pre-filled syringes, supporting the identification and mitigation of recurring usability risks across devices.
• ● Defined and documented the usability engineering plan to guide the project through design, development and regulatory submission stages.
• ● Directed evidence-based design solutions by synthesizing user research insights, stakeholder feedback, and industry best practices to address challenges in usability and differentiation.
• ● Conducted use related risk analysis (URRA) to identify, document, and address potential safety and usability concerns, harms, severity levels, particularly for pediatric users in high-stake emergency situations.
• ● Led and mentored Human factors engineers in conducting threshold analysis, providing training and gu
UL- Solutions
Human Factors Engineer I
April 2022 - May 2024 (2 years and 1 month)
2750 Ballerup, Denmark
• ● Supporting, leading and developing comprehensive human factors engineering project plans to ensure well-scoped human factors activities are performed throughout product development in accordance with IEC/ANSI/AAMI 62366 - 1 and 2, FDA HF engineering guidance and IVDR/MDR.
• ● Design control test and validation in accordance with ISO 13485 and FDA 21 CFR 820.
• ● Managing/supporting in recruiting test participants for larger (+30) and smaller studies (+10) in both the U.S and EU.
• ● Stakeholder communication throughout project work, including R&D, Project Managers, Regulatory and clinical teams ensuring proper alignment on tasks.
• ● Establish risk management framework for different medical devices, in accordance with ISO 14971 .
• ● Risk analysis and assessment with clinical experts.
• ● Developing instruction for use in English, as well as supporting the UX team.
• ● Developing test protocols for both formative and summative reports.
• ● Developing packaging and design for pre-filled syringes and combo products.
• ● Planning, recruiting and conducting usability tests according to FDA expectations.
• ● Planning, managing, and conducting usability tests throughout the product development process in both the U.S. and UK.
• ● Planning, managing, and conducting user research to identify user needs.
• ● Analyzing usability test data and developing reports describing opportunities for improvement.
• ● Developing design recommendations that facilitate intuitive and safe use for Pre-Filled Syringes/ Pen injectors (combo products), cardiac monitors, insulin pumps, IT system interfaces (software) and blood gas analyzer, endoscopes.
• ● Performing and supporting analysis activities including task analysis, use- related risk analysis, known problems analysis (MAUDE), root cause analysis.
• ● Summative and formative reporting.
• ● Performing inferential statistical analyses.
• ● Diversity, Equity and Inclusion for the European, U.K and U.S team.