Job Description

Medical Engineering Consultants (MEC) support medical device and pharmaceutical companies to be more efficient and productive by providing resources, knowledge, and expertise to augment and supplement to their work. Our vision is to closely align our clients’ needs with the best resources available in the marketplace. We take proactive, preventative, and corrective action and create a roadmap for ongoing future improvement by identifying, integrating, and executing sustainable solutions that validate processes, ensure fully compliant quality systems, and close gaps between current and FDA expected stages. MEC offers companies short or long-term support — from high-end leaders, managers and consultants to skill-set Engineering staff and SME’s (Subject Matter Experts). MEC's mission is to inspire positive cultural change from within, and always exceed our clients’ expectations. Day To Day Responsibilities Perform human usability engineering activities in partnership with functional engineering groups, Software, Firmware, Electrical, Mechanical and Systems, new product planning, clinical, design assurance, regulatory and marketing. Develop research methodologies to collect both qualitative and quantitative data as needed. Design and execute both formative and summative usability tests to simulate product use. Support and author deliverables related to user needs, development of user profiles, use scenarios, task and use error analysis, usability testing and post-market usability analysis for continuous improvement. Maintain positive and cooperative communications and collaboration with all levels of employees, customers, contractors and vendors and across multiple disciplines Must Have The Following Requirements ~ Degree types: Pre-med, Human Factors, Psychology Bio-med related. ~4 Years of relevant work experience in medical device product development and/or a graduate degree with a relevant project experience. ~ Prior experience working with medical device hardware, ideally class III implantables ~ Strong analytical and problem-solving skills in a team environment ~ Experience moderating usability sessions and documenting findings ~ Ability to work within a team and as an individual contributor in a fast-paced dynamic environment ~ Excellent verbal and written communication skills and the ability to positively influence individuals and groups ~ Strong organizational skills as well as attention to detail ~ Knowledge of IEC 62366, 60601-1-6 and FDA guidelines for Human Factors. ~ This must be clearly indicated on resume. Quality Systems Duties And Responsibilities Build Quality into all aspects of their work by maintaining compliance to all quality requirements. Possible 10% or 3-times during assignment, the person will travel (US). MEC does not accept unsolicited resumes through or from search firms or staffing agencies. All unsolicited resumes will be considered the property of Medical Engineering Consultants (MEC) and will not be obligated to pay a placement fee. ~ Sponsorship is not available for this position Check us out at AAP/EEO DFWP Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. Other Duties Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Job Tags

Temporary work, For contractors, Work experience placement,

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