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Planet Pharma seeks an experienced Human Factors Engineer to lead HF validation for a Class III medical device. You will own study protocols, ensure accurate risk traces, recruit participants with research ops, moderate sessions, analyze data, and write comprehensive reports.
The role requires 5–10 years of relevant experience, strong collaboration with HFE and systems engineers, and the ability to translate usability data into design recommendations for clinicians and patients.
Can you please confirm your top 3 skills sets required? Human Factors validation study design and execution (as moderator), Use Related Risk Analysis author, usability data analysis and report writing
Can you please confirm the 3 main responsibilities/day to day activities required for this role? This individual will work on a team with multiple HFE and systems engineers focused on formative, presummative, and HF validation for a class III medical device. They will be responsible for owning a study protocol - writing the protocol and ensuring that risk traces are accurate, working with research operations on participant recruitment and other study logistics, moderating formative and summative study sessions, completing data analysis, partnering with other functions to discuss design recommendations based on usability data, and writing reports
What products (if any) will this role support? Sacral neuromodulation system - particularly the use of clinician components of the system
What is your target years of experience? 5-10 years
Responsibilities may include the following and other duties may be assigned. Applies human performance principles, methodologies, and technologies to the design of humanmachine systems and products. Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of products development and processes. Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, userelated risk identification and formal usability validation with intended users. Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized humanmachine interfaces. Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.
Specialist CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).
DIFFERENTIATING FACTORS
Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists; may manage projects / processes.
Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.
Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.
Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking.
Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area. May manage projects, requiring delegation of work and review of others' work product .
Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management. Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.