Human Factors Engineer – Combination Product Development
Location: California Hybrid
Sector: Biotechnology | Medical Technology | Pharmaceuticals
At NexGen Search, we’re partnering with a global biopharmaceutical leader to identify an exceptional Human Factors Engineer (HFE) to join their dynamic product development team. This is a rare opportunity to play a critical role in shaping innovative combination products that enhance patient safety, usability, and outcomes worldwide.
The Opportunity
In this role, you’ll lead and support human factors engineering (HFE) strategies from early feasibility through clinical development, regulatory submission, and post-market stages. You’ll collaborate with cross-functional experts to ensure every product is designed with the end user in mind—balancing innovation, compliance, and human-centered design.
Key Responsibilities
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Drive or support HFE strategy and execution across all stages of combination product design and development.
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Conduct user requirements definition, use-related risk analyses, and usability studies (formative and summative).
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Develop clear and effective user instructions, training materials, and supporting documentation.
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Author and maintain HFE deliverables for design history files and regulatory submissions.
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Educate internal teams on the HFE process and foster a user-centered design mindset.
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Partner with external HFE consultancies to coordinate study design, execution, and reporting.
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Contribute to improving internal HFE processes to ensure consistency and compliance.
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Ensure all work aligns with company SOPs and regulatory requirements for HFE and risk management.
What You’ll Bring
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Bachelor’s degree in Mechanical, Chemical, or Bioengineering (with 6+ years’ experience), or
Master’s degree in a related field (with 4+ years’ experience). -
Proven experience leading HFE activities for medical device or combination product development.
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Strong working knowledge of human factors regulations, design controls, and risk management standards.
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Excellent communication and documentation skills, with the ability to influence cross-functional teams.
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Ability to analyse data, identify design improvements, and communicate findings clearly.
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Experience collaborating with vendors, consultants, and regulatory stakeholders.
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A proactive, detail-oriented mindset with the ability to manage multiple priorities and timelines.
Leadership Qualities
As a leader within the team, you’ll be expected to:
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Create Inclusion – value diversity and foster a collaborative environment.
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Develop Talent – coach and empower team members to reach their full potential.
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Empower Teams – align team goals with organisational objectives and remove barriers to success.
Why Apply Through NexGen Search?
At NexGen Search, we connect forward-thinking professionals with organisations that are redefining the future of healthcare and technology. We specialise in roles that bridge innovation, science, and human impact—helping you find opportunities where your work truly matters.
If you’re passionate about advancing patient-centric design and driving meaningful change in healthcare, we’d love to hear from you.