Senior Human Factors Engineer - Medical Device Usability

Sr Human Factors Design Eng

Primary Talent Partners has a new contract opening with our medical device client in Minneapolis, MN. This is a 12-month contract with a potential for extension.

$65.00 - $75.00/hr; W2 contract, no PTO, no benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and must be able to sit on Primary Talent Partners W2 without sponsorship.

On-site, with option to work from home 1 day a week (generally on Friday).

Responsibilities may include the following and other duties may be assigned:

• Applies human performance principles, methodologies, and technologies to the design of human machine systems and products.
• Develops and implements research methodologies and statistical analysis plans to test and evaluate developmental prototypes used in all phases of product development and processes.
• Designs and executes tests to simulate product use for the purposes of concept selection/refinement, requirements development, use related risk identification and formal usability validation with intended users.
• Interfaces with design engineers to establish system design, operating, and training requirements and to ensure optimized human machine interfaces.
• Identifies and analyzes technological problems or risks, performs theoretical human factors investigations, and develops and implements research and analysis plans.

• Bachelor's degree in Human Factors Engineering, Industrial Engineering, Biomedical Engineering, Psychology, Human-Computer Interaction, or related technical field
• Minimum 5 years of experience in Human Factors / Usability Engineering within a regulated industry; medical device experience strongly preferred
• Experience conducting human factors usability validation studies, including protocol development, study execution, data analysis, and final report authoring
• Strong knowledge of FDA Human Factors guidance, IEC 62366, and use-related risk management processes
• Experience generating, revising, and maintaining Use-Related Risk Analyses (URRA)
• Experience supporting Class II or Class III medical devices; implantable device experience preferred
• Ability to collaborate cross-functionally with engineering, quality, regulatory, clinical, and product development teams
• Strong technical writing and documentation skills
• Experience identifying use-related hazards and translating findings into design recommendations
• Familiarity with formative and summative usability testing methodologies
• Strong analytical, problem-solving, and communication skills
• Ability to manage multiple priorities in a fast-paced product development environment

• Advanced degree (MS or PhD) in Human Factors, Human-Computer Interaction, Biomedical Engineering, or related field
• Prior experience supporting neuromodulation, neurostimulator, or other implantable medical device products
• Experience working within FDA-regulated and ISO-compliant quality systems
• Experience with statistical analysis and human performance evaluation methods
• Previous experience working with global or cross-functional product development teams

• Human factors usability validation and generating use-related risk analysis

Primary Talent Partners is an Equal Opportunity /Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

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