CP Professional Services (CP) is a full service Life Sciences Quality and Compliance consulting firm also offering Engineering headquartered in Sparta, New Jersey with offices in Florham Park NJ and San Diego CA. CP is committed to our clients and develops innovative strategies and targeted solutions necessary to exceed standards and our clients' individual needs, goals and expectations.

CP is ranked 3rd in the NJBIZ Top 50 Companies to Work for and is listed in NJBIZ 50 Fastest Growing Companies in NJ.

CP is seeking for our Bio-Pharmaceutical Client, one local Sr. Human Factors Engineer for a 12+ month onsite assignment in Columbia MD. The client is interested in converting the consultant to a full time employee after six months of consulting.

ROLE SUMMARY

This role’s primary purpose is for ensuring that assigned devices, associated labelling and packaging, and training (if applicable) are designed to be safe and effective for use by intended users within intended environments for all chosen markets. As part of the product development teams, this role will be accountable to work with external design companies and human factors vendors in developing and ensuring timely execution of human factors engineering deliverables for assigned devices. Performs human factors (usability studies), market assessment, or pre-clinical research.  Responsible for adhering to design controls and documenting all product development work in a Design History File.

ROLE RESPONSIBILITIES

• Generate and ensure approval of all device human factors engineering documentation for assigned projects
• Perform task analysis and use error assessment to identify critical and essential tasks. Provide input into risk management activities for assigned projects ensuring risk files are aligned with human factors activity and feedback
• Provide device usability input/support to device design inputs and device design specification
• Generate Human Factors and Design Validation objectives and deliverables plan, and documents goals and strategies within a Design Validation and HF plan
• Manage all human factors (HF) activities associated with HF vendors, including on boarding of HF vendor, generation of study brief, attainment of HF vendor proposals, assignment of HF vendor, providing all relevant materials and documentation, management of HF studies, and generation and approval of associated reports
• Project manage the supply, assembly and testing of materials for use in HF studies and associated documentation
• Report any adverse findings or adverse events witnessed at HF studies and ensure appropriate action
• Ensure timely execution of HF studies for assigned projects
• Provide HF study feedback and/or recommended mitigation actions into the project Core Team
• Provide input and support for generation of assigned Clients device Instructions for Use (IFU), device labelling and packaging
• Design and ensure full change control for IFU documentation where applicable for assigned projects
• Ensure work is done in compliance to design control regulations and company policies and procedures
• Support the generation of device regulatory submission data. Ensure high quality deliverables in compliance with Regulation and local procedures.
• Assist in the application of HF engineering principles and controls for all device development projects
• Support and conduct human factors research to augment present and future device projects including in-house laboratory testing and external research with the support of contract staff/vendors
• Support internal and external audits of HF related aspects of the Quality System

BASIC QUALIFICATIONS

• B.S. Degree in human factors engineering, experimental psychology, cognitive psychology, industrial design or a related field with 5 – 7 years experience
• M.S Degree in one of the above disciplines 3 – 5years experience
• Ph.D. in Engineering discipline with 1 – 3 years experience

(Biomedical Engineering or Mechanical Engineering preferred for second or third degree)

PREFERRED QUALIFICATIONS

• Human factors and usability engineering
• Proficiency in design software (preferably Solidworks) and other general computer software such as word processing, spreadsheets, presentations, etc.
• Strong mathematical, analytical, and reasoning skills
• Strong problem solving skills
• Strong innovation skills
• Strong creativity astuteness
• Strong research skills
• Strong organizational skills
• Strong in team work
• Strong written and oral communication
• Experience in complying with FDA Design Control Regulations for Combination Products per 21 CFR Part 4 and/or Medical Devices per 21 CFR 820.30 and EU Medical Device Directives
• Ability to prioritize multiple responsibilities and to work on multiple projects simultaneously
• Responds to requests for service and assistance with professionalism, courtesy, and confidence

All your information will be kept confidential according to EEO guidelines.