Principal Human Factors Engineer (Minneapolis)

IDE Group | Minneapolis IDE Group is a global MedTech venture partner. We work with founders, clinicians, universities & executives to turn high-impact healthcare ideas into regulated, commercial medical device businesses. Our teams operate across Australia, the United States & Europe, delivering products from first prototype through to clinical, regulatory approval & market launch. We are now looking for a

Principal Human Factors Engineer

to lead and elevate human factors strategy across some of IDE’s most complex and strategically important MedTech programs.

The Role As a Principal Human Factors Engineer at IDE, you will lead end-to-end human factors and user research strategy across medical device development programs spanning early discovery through to validation and regulatory submission. You will work directly with client leadership teams, IDE project leaders, and cross-functional engineering teams to ensure products are safe, intuitive, clinically meaningful and commercially viable. This is not a support role. You will be accountable for human factors vision, execution quality, regulatory alignment and team leadership across multiple concurrent programs. You will typically be responsible for: Leading human factors engineering strategy from early generative research through formative studies and summative validation Planning and conducting ethnographic research, contextual inquiry and stakeholder insights to define meaningful user needs Translating research into requirements, opportunity areas and measurable usability objectives Performing workflow analysis, task analysis and use-related risk analysis (URRA) Designing, planning and executing formative and summative usability studies, including protocol development and reporting Ensuring alignment with global regulatory expectations (IEC 62366-1, ISO 14971, ISO 60601 and related standards) Working cross-functionally with systems, software, hardware, quality and regulatory teams to embed sound human factors principles into product architecture Defining appropriate processes, methods and quality standards for program deliverables Identifying and managing use-related and product risks in collaboration with project leadership Contributing to proposal development, client strategy discussions and early-stage opportunity shaping Mentoring and developing human factors engineers and broader team members within IDE Who this role is for This role is designed for someone who is already operating at senior level in human factors or usability engineering within regulated product development and is ready to lead strategy, clients and teams.

You will likely have: A degree in Design, Human Factors Engineering or a related discipline 7+ years of human factors/usability engineering experience in medical devices or other regulated industries Deep experience across the full product lifecycle — from generative research through validation testing Demonstrated experience applying IEC 62366-1, ISO 14971 and related medical device standards A strong track record of authoring and executing Human Factors Engineering plans Experience conducting ethnographic research, task analysis, user error analysis and validation studies Confidence leading cross-functional teams and influencing engineering and regulatory decision-making Strong client presence and the ability to represent human factors strategy in executive-level discussions Experience mentoring, coaching and growing technical team members Excellent written, verbal and presentation skills You do not need to be a regulatory specialist, but you must be confident leading human factors activities in highly regulated environments.

Why join IDE At IDE, Human Factors is not a checkbox at the end of development. It is central to how we build ventures, reduce risk and create differentiated medical products. You will get: Ownership of human factors strategy across high-impact MedTech ventures Exposure to founders, investors and global partners Projects ranging from connected diagnostics and digital health to capital equipment, drug-device combinations and automation platforms The opportunity to shape how human factors is embedded across global programs A clear pathway into Practice Leadership, Program Leadership or broader Venture Leadership roles A culture that values curiosity, accountability, technical excellence and commercial thinking If you are looking for a role where you can shape product strategy, influence regulatory outcomes and build meaningful medical device businesses through human-centred design, this is that role.