Job Description

Company Overview

Respair is a clinician-founded, SBIR- and venture-backed medical device startup on a mission to develop next-generation airway devices that improve outcomes for vulnerable patients and boost provider efficiency.

Location

Pittsburgh, PA (Hybrid: in-office/lab Tue–Thu, remote Mon & Fri)

Job Type / Compensation

• This is a contract-to-hire role, offering $30–$40/hour for an initial 3-month period, with the intention of converting to full-time.
• If converted to full-time: $70,000–$90,000 / year with full-time benefits: vision, dental, medical, 401(k) + stock options

Position Summary

As a Product Development Specialist, you’ll lead prototype, testing, and brainstorming iteration cycles (60% build/test) while also supporting regulatory, documentation, and market/commercial activities (40%).

Key Responsibilities

Lead Prototyping & Design Iteration (60%)

• Own rapid prototyping workflows: 3D printing, machine operations at our robotics factory residency, and post-processing
• Coordinate CAD updates and design-for-manufacturability reviews in Fusion 360
• Analyze test results and propose data-driven design optimizations.

Regulatory & Quality Management System Support (15%)

• Draft and review validation protocols (IQ/OQ/PQ) and traceability matrices
• Coordinate with QA/RA to ensure compliance with FDA design controls and ISO 13485

Market Research & Commercial Support (15%)

• Assist in customer feedback synthesis and competitive product benchmarking
• Contribute to commercialization strategy discussions

Documentation and communication (10%)

• Prepare technical reports, design history files, and change-control documentation.
• Maintain version control on CAD files, BOMs, quality documents, and reports to ensure accurate and up-to-date information.
• Utilize tools like Fireflies, Slack, and Asana for asynchronous communication with our larger team and advisors

Qualification:

• 3+ years in device R&D, prototype development, or product support roles
• Fusion 360 or SolidWorks CAD expertise
• Hands-on experience with 3D printing, CNC machining, and prototype post-processing
• Demonstrated test-driven design iteration and data analysis skills
• Familiarity with FDA design controls, GMP documentation, and ISO 13485 environments
• Excellent communication, organization, and cross-functional coordination skills
• Self-driven – this is not a role where you’ll be micromanaged. Comfort with ambiguity and knowing when to ask for help will be essential to success.

Education: Preferred degrees in Mechanical or Biomedical Engineering, but we value skills over formal credentials—any background is welcome to apply.

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