Job Description

The Senior Specialist, Human Factors position will be responsible for performing and managing human factors activities to ensure compliance with US and global regulatory policies/guidance for all combination products and medical devices in the company's portfolio and pipeline including acquisition products. The Senior Specialist will apply knowledge of human performance (perceptual, cognitive, and motor skills) and Human Factors techniques to a wide range of systems’ issues, across the product lifecycle: including customer needs identification, early product device concept selection/screening, user profiles, task analysis, user interface design, use error analysis, risk assessment and mitigation, usability testing, hazard analysis, and post-launch outcomes analysis.

Principal Responsibilities

Perform and manage human factors activities throughout the whole product design and development cycle within the constraints of a regulated environment, including creating human factors plan, working with other disciplines to identify customer needs, intended use and potential hazard/harm, providing product and packaging design inputs/requirements, performing task analysis and use error analysis, designing instructions for use, conducting formative/summative studies, preparing regulatory submission materials, addressing post market surveillance and training need.

Collaborate with cross-functional colleagues to create innovative and intuitive-to-use products and ensure regulatory compliance through risk management. The cross functional team includes marketing, product planning/project managing, formulation development, clinical, safety, regulatory, purchasing, manufacturing, packaging and labeling.

Responsible for key development deliverable documents, ensure the management and maintenance of documents, records and databases that support regulatory compliance (such as human factors study protocol and report, Task analysis and use error analysis document etc)

Support other quality and GMP compliance activities relating to combination products and medical devices

Perform other job related duties or special projects as required.

Qualifications

MINIMUM REQUIREMENTS:

B.A./B.S in Human Factors, Ergonomics, Cognitive or Experimental Psychology, Sociology, Engineering, Chemistry or Business Management plus five years of related experience or M.A/M.S. with three years of related experience or PhD in one of the above disciplines

Proven track record of applying analytic skills in the product design, development and evaluation

Strong project management skills

Self-motivated and work independently

Proven ability to work with multidisciplinary teams.

Strong interpersonal skills and a strategic thinker; able to influence without formal authority; ability to influence and present ideas to senior leadership

Excellent communication, presentation, negotiation, project management and organizational skills.

Willing to travel, approximately 10% based on projects

Able to quickly pick up advanced domain knowledge and conduct literature search as needed.

Able to multi-task continuously.

PREFERRED REQUIREMENTS:

M.A/M.S. or PhD in one of the above disciplines

Working knowledge of medical device or pharmaceutical industry.

Knowledge with U.S. and global Medical Device and healthcare regulations, including FDAs combination products cGMP, Quality System Regulation, FDA Human Factors guidance, ISO 14971, EN 62366, Council Directive 93/42/EEC, etc.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.