Human Factor Design Engineer

  Medical Writing

Job title: Human Factor Design Engineer

Company: Freelancer – Vikas Gaikwad

Job description: We are looking for a Human Factor Engineer who can write up medical device usabilitydocumentation (IEC 62366-1), perform human factors validation, and ideally has experience indesigning workflows or software UIs.

Job Title:- Human Factor Design Engineer Job Location: Pune Work from home Immediate Joiners 15 to 30 days Experience:- 3+ Required Skills:- Summary We are looking for a Human Factor Engineer who can write up medical device usabilitydocumentation (IEC 62366-1), perform human factors validation, and ideally has experience indesigning workflows or software UIs. Educational Qualification Bachelor’s in human Factors Engineering/Industrial Engineering/Human Computer Interaction/Cognitive Psychology or other relevant engineering discipline Requirements (Must have) 3+ years of experience in writing medical device usability documentation (IEC 62366-1 ) Extensive knowledge of HFE requirements /standards Understanding of HFE principles in ergonomics, human computer/machine interface, and data collection / analysis methodologies. Experience with risk management activities applied by Human Factors to medical devices (e.g. UEA, AFMEA, UFMEA, URA techniques). Experience planning, scaling, documenting, and executing human factors program activities in accordance with FDA guidance and other relevant international standards (e.g. , IEC62366, IEC 60601, ISO 14971) Experience in perform human factors validation and verification of medical products Strong experience in designing workflows and software Uis Good understanding of user centred design, heuristic evaluations, design of experiments, and statistical analysis. Excellent understanding of design requirements of development Requirements (Good to have) Prior experience independently developing biological safety assessments for inclusion with regulatory submissions is preferred. Knowledge of standards for biocompatibility of breathing gas pathways in healthcare applications, e.g. ISO 18562, is preferred. Industry experience in medical device materials and product development is preferred. Experience in supporting regulatory submissions, namely 510ks, is preferred. Experience working with internal and external scientific standard organization (e.g. ISO/TC194) is preferred. Experience of working on Agile projects Soft skills (Must have) Excellent communication and presentation skills Positive attitude towards learning/challenges/team/etc. Planning and organizational skills to prioritize and handle multiple tasks. Essential Duties & Responsibilities Leading human factors engineering work and research for medical devices and regulated products with minimal supervision. Designing and executing tests to simulate product use for validating and verifying product performance, reliability, and usability. Actively participating on device programs to ensure sound human factors principles are considered and implemented. Collaborating with various team to develop product prototypes to explore and validate user interfaces and demonstration prototypes Drawing conclusions and making recommendations based on a variety of technical inputs. Solving human factors engineering problems with minimal assistance. Interested candidate revert with:- 1. Updated resume 2. Total experience 3. Relevant experience 4. Current CTC 5. Expected CTC 6. Official Notice period( LWD if serving NP)

Expected salary:

Location: Pune, Maharashtra

Job date: Mon, 31 Jan 2022 23:21:09 GMT

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