Sr Human Factors Engineer, R&D at Collins Consulting Burlington, MA

Sr Human Factors Engineer, R&D job at Collins Consulting. Burlington, MA.

This is an onsite position. Local candidates only

Senior Human Factors Engineer, R&D

Leading an active lifestyle is important to the many people we serve. In Client's Heart Failure division, we're advancing the treatment of heart disease through breakthrough medical technologies in heart failure, allowing people to restore their health and get on with their lives.

Description

We are seeking an experienced, high caliber Senior Human Factors Engineer to support product development efforts by performing clinical engineering tasks such as investigating, defining, analyzing, documenting, and testing activities associated with the development of heart failure devices. Human Factors Engineering performs additional analyses and/or interviews to determine the requirements and constraints on the system and is accountable for resolving cross-functional issues. Work requires the application of theoretical principles, evaluation, ingenuity, and creative/analytical techniques.

Each employee can make a difference at the client and has the power, either individually or as a team, to influence the success of the company. We value people with great ideas who partner with others internally and externally to take action and accomplish goals.

The Senior Human Factors Engineer will

Perform all activities necessary to complete human factors engineering projects with minimal oversight. Activities include, but are not limited to: Conducting ethnographic user research to identify user needs

Translating user needs to requirements and product design concepts

Developing prototypes to explore and validate product design concepts

Performing workflow, task and use error analyses and/or UFMEAs

Developing user-facing instructions

Conducting formative usability testing

Conducting summative usability validation testing

Participate on development program teams to ensure sound human factors principles are considered and implemented.

Participate in teams to design solutions to usability issues

Provide input to the risk management process, including risk brainstorming, and identification of patient harms and associated severity/probability.

Foster collaboration with cross-functional teams and leaders to drive work to completion and resolve issues.

Support all company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements

Comply with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.

Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors

Perform other related duties and responsibilities, on occasion, as assigned

Your experience(s), education, and knowledge

Required Bachelor's Degree in human factors engineering, human computer interaction, human factors psychology, or a related Engineering degree with Human Factors experience.

5+ years of R&D experience in medical device development and/or other highly regulated industry. (Advanced degree may substitute for some experience.)

General knowledge of user interface design, human perception, cognition, anthropometry, biomechanics, human behavior, and physiology.

Demonstrated ability to effectively integrate information from to varied disciplines including Engineering, Marketing, Clinical Affairs, and Regulatory Affairs.

Demonstrated leadership in team settings , including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results

bility to leverage and/or engage others to accomplish projects • Ability to travel, including internationally

MS Office Suite

Meets deadlines in a timely manner

bility to leverage and/or engage others to accomplish projects

bility to travel, including internationally

Preferred Master's Degree in human factors engineering, human computer interaction, human factors psychology, or a related Engineering degree with Human Factors experience

Class III implantable medical device experience

Excellent interpersonal and communication skills (verbal, written, presentation), with ability to clearly communicate complex information across all levels of the organization Strong analytical, problem-solving skills

bility to work in a highly matrixed, geographically diverse, fast-paced business environment

If someone has working knowledge of Regulation 623.66 and FDA this is a nice to have. Collins Consulting