HF and Usability Manager

Job Title: HF and Usability Manager

Location: St. Lawrence, Massachusetts

Job Type: 12+Months Contract / Full Time

Job Description:

• 8+ years related experience in Human Factors / Usability Engineering and/or product design, development, or testing; experience with class II medical device products is preferred.
• 3+ years supervisory or project/program management experience preferred
• Subject-Matter Expertise (SME) understanding of medical device product design and regulatory processes.
• Excellent communications, writing, and presentation skills.
• Ability to interface with customers in a highly professional manner
• Excellent technical communication skills and attention to detail, including creating and editing technical research, analyses, protocols, and reports
• Ability to analyze and synthesize large quantities of information into usable communications.
• Ability to prioritize and multi-task in a fast-paced, collaborative work environment
• Ability to work independently and resolve cross functional issues independently
• Detailed understanding of system, electrical, and mechanical design, as well as software integration.
• Prior experience with complex electro-mechanical systems preferred, especially systems having fluidic and/or disposable components is a bonus
• Experience in the application of best-practice product development methodologies, especially as they relate to the application of Human Factors and usability engineering principles.
• Experience leading: formative and summative usability evaluations (structuring, recruiting for, conducting, and reporting on), especially involving class II or III medical devices
• Expert level understanding with medical device design and development processes that conform to standards including: ISO 9000, ISO 13485, IEC 62304, IEC 60601, IEC 62366-1, IEC TR 62366-2, and ISO 14971.
• Experience working with third-party service providers and external certification laboratories is a bonus