Senior UX Designer, Product Development - Medical Devices/FDA
Posted 2 days ago by 1753858648
Negotiable
Outside
Remote
USA
Summary: The Senior UX Designer role focuses on designing user interfaces for medical devices and other regulated environments, requiring recent experience in FDA-regulated settings. Candidates must provide a portfolio demonstrating their ability to simplify complex systems and adhere to regulatory standards. The position is contract-to-hire, with remote work and quarterly travel to Naples, FL. Strong documentation and traceability skills are essential for compliance with design controls and validation processes.
Key Responsibilities:
- Design user interfaces for medical devices and regulated product ecosystems.
- Create traceable UX documentation to support design controls and compliance.
- Collaborate with cross-functional teams to ensure usability and regulatory adherence.
- Travel to Naples, FL once a quarter for client meetings.
Key Skills:
- Recent experience in medical device design and FDA-regulated environments.
- Strong portfolio demonstrating UX design for complex systems.
- Knowledge of FDA, ISO 13485, IEC 62304 standards.
- Ability to create rationale-driven design decisions and documentation.
Salary (Rate): undetermined
City: undetermined
Country: USA
Working Arrangements: remote
IR35 Status: outside IR35
Seniority Level: undetermined
Industry: Other
Senior UX Designer, Product Development
Duration: 12+Months
Required Location: Remote with travel to Naples, FL once a Quarter PAID FOR BY THE CLIENT.
Opportunity Type: Contract-to-Hire
A senior UX Designer with Recent Medical device experience and a recent Portfolio. Candidates must have experience working within FDA-regulated environments or equivalent. interfaces for products governed by FDA, ISO 13485, IEC 62304, or similar standards. Must have experience designing for FDA-regulated or equivalent environments (e.g., ISO 13485, IEC 62304), with documented UX traceability.
CANDIDATES MUST PROVIDE A LINK TO THEIR PORTFOLIO. Portfolio must demonstrate simplification of complex systems, rationale-driven design decisions, and documentation that supports traceability, validation, and design controls.
Job Description:
INDUSTRY BACKGROUND REQUIRED
Candidates must have direct experience designing user interfaces for regulated, complex product ecosystems. Acceptable industries include:
- Medical devices
- Surgical platforms
- Healthcare technology involving hardware/software integration
- Other industries with high technical complexity and regulatory oversight
Preferred employers include:
Apple (hardware), Meta (Reality Labs), GE Healthcare, Medtronic, Stryker, Philips, Smith & Nephew
REGULATORY EXPERIENCE REQUIRED
Candidates must have experience working within FDA-regulated environments or equivalent. This includes:
- Designing interfaces for products governed by FDA, ISO 13485, IEC 62304, or similar standards
- Creating traceable UX documentation to support design controls, validation, and compliance
- Understanding of usability requirements and regulatory submissions for digital products in healthcare or life sciences
Note: Candidates without experience in FDA-regulated or equivalent environments should not be submitted.
PORTFOLIO REQUIREMENTS Portfolios Must Include:
- Demonstrated ability to simplify complex technical systems through UX
- Polished, minimalist visual design across platforms
- Rationale and traceable documentation that aligns with FDA or regulatory design processes
Portfolios Will Not Be Considered If They Contain:
- Marketing, branding, or brochure-style work
- General consumer-facing or basic healthcare apps
- Non-product-focused or utility-based examples