Pay 65-75 depending on experience
Can you please confirm your top 3 skills sets required? Human Factors Engineering for Class III medical devices Experience navigating complex regulations including FDA QSR, CFR 820, ISO13485, ISO14971, IEC62366 and EU Medical Device Regulations Use Error Analysis Can you please confirm the 3 main responsibilities/day to day activities required for this role? Responsible for providing human factors engineering support to ensure the successful development of Medtronic Neuromodulation devices and ongoing operational support Responsible for risk analysis activities including task analysis, use error analysis, and use related risk analysis Responsible for product design evaluation activities including simulated use testing, heuristic reviews, formative evaluations, summative validation, and analysis of post-market surveillance data What products (if any) will this role support? Deep Brain Stimulation (DBS) systems Spinal Cord Stimulation (SCS) systems What is your target years of experience?5-10 yearsResponsibilities 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.
