Senior Design Quality Engineer

We’re Cubby Beds 👋

A fast-growing and high-impact startup that makes smart beds for people with cognitive conditions like Epilepsy, Cerebral Palsy, Dementia and Autism. Our mission is to improve the lives of special needs kids and their families through our innovative products and go to market strategies. Since launch, we have changed the lives of thousands of families, been insurance covered in all 50 states, achieved profitability, and are building a growing team in our Denver HQ.

The next stage of the business is all about scaling our team, product, systems, and customer journey to help thousands more families get the safe sleep they deserve.

This is where you come in

When you join Cubby, you’re joining a team of entrepreneurs and creators who are on a mission to change the lives of thousands of special needs families. As our first internal Design Quality Engineer, you will be an integral part of a Quality team driven by a shared purpose: to create products that have a profound and life-changing impact. You'll contribute directly to the development of these critical devices, working alongside Product, Supply Chain, and Growth teams. This is an opportunity to apply your hardware quality expertise in a startup environment where your contributions directly translate into tangible improvements in the lives of our users and their caregivers.

Here’s what you’ll be doing

• Quality Leadership in Design & Development: Serve as the primary quality representative on design and development teams for our Class I medical devices.

• Design Planning: Develop and implement robust Design and Development Plans for product development projects, ensuring adherence to relevant regulations (e.g., 21 CFR Part 820), standards (e.g., ISO 60601-1-1), and internal procedures.

• Design Control Expertise: Drive the effective application of design control principles throughout the product lifecycle, including design inputs, design outputs, design verification, design validation, design transfer, and design changes.

• Hardware Focus: Leverage your deep understanding of hardware and soft goods development processes, including mechanical, electrical, and materials engineering, to identify and mitigate quality risks.

• Risk Management: Facilitate and participate in risk management activities (e.g., hazard analysis, FMEAs) to proactively identify and address potential safety and performance issues.

• Verification & Validation (V&V): Plan, execute, and oversee verification and validation activities, ensuring that design outputs meet design inputs and that the final product meets user needs and intended use. This will heavily involve hardware testing and analysis.

• Documentation Control: Ensure the creation, review, and approval of accurate and complete design and development documentation, including drawings, specifications, test protocols and reports, and design history files (DHFs).

• Supplier Quality: Collaborate with sourcing and manufacturing teams to establish quality requirements for suppliers of components and sub-assemblies prior to design transfer.

• Regulatory Compliance: Stay abreast of relevant medical device regulations and standards, ensuring that our design and development activities are compliant.

• Problem Solving: Investigate and resolve design-related quality issues, implementing effective corrective and preventive actions (CAPAs).

Here’s what we’re looking for

• You will have at least:

  • Bachelor's degree in Engineering (Mechanical, Electrical, Biomedical, or related field).

  • Minimum of 5-7 years of experience as a Quality Engineer in a regulated environment, preferably within the medical device industry.

  • Significant hands-on experience with hardware development and quality assurance for physical products.

  • Proven experience implementing and maintaining design control processes (21 CFR Part 820, ISO 13485).

  • Experience with verification and validation testing, particularly for hardware components and systems.

  • Excellent technical writing and communication s