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 Senior 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 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 skills.

  • Strong problem-solving and analytical skills.

  • Ability to work independently and as part of a cross-functional team.

• We hope you also have

  • Direct experience working with Class I medical devices is highly preferred. Direct experience working with a variety of medical devices is required.

  • Prior experience in a startup environment is preferred, demonstrating the ability to be adaptable, resourceful, and thrive in a fast-paced setting.

  • Strong understanding of risk management methodologies (e.g., FMEA, hazard analysis).

  • Familiarity with statistical analysis and quality tools

• Bonus Points

  • Experience with software quality assurance in the context of embedded systems or device software.

Don’t feel like you have all of the qualifications?

The description above indicates our current vision for the role. You could be a viable candidate even if you don't fit everything we've described above and may also have important skills we haven't thought of. If that's you - even if you’re unsure - we encourage you to apply and help us get to know you!

Benefits & Perks✨

• Compensation: $115-145k hiring range - Cubby offers an exciting OTE (On-Target Earnings) program to motivate and celebrate collective success in achieving company goals. The total cash compensation range listed above is inclusive of base pay & target variable pay. The target variable pay for this role is 10% of the base salary.

• Stock Options - Equity Ownership

• Health, Dental, and Vision Insurance

• Unlimited PTO & Sick/Wellness Hours

• 12 paid holidays + a paid volunteer day

• 401k with a company match

• Hybrid Work Model: Monday-Wednesday in the office, optional work from home Thursday-Friday

• Mac, standing desk, and high-end accessories at the office + a work-from-home stipend to purchase equipment needed for home offices

• Paid parking

• Annual staff retreat

• Stocked kitchen and bimonthly team lunches in our beautiful Denver HQ

• Growth opportunities at a start-up with a life-changing mission

If you have the desire to design & build products in a high-growth org that also changes lives, we want to meet you! Interested? Apply now! 👩🏻‍💻

As part of the application process, we may request a short introductory video to get to know candidates beyond their resumes and fairly evaluate important communication and presentation skills. We understand video submissions may not be possible for everyone—if that’s the case, please reach out to recruiting@cubbybeds.com for alternative options. Effective communication is essential for this role, and we’ll gladly consider reasonable accommodations. By submitting your application, you acknowledge these terms.

Cubby Beds is committed to creating a diverse environment and is proud to be an equal-opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity or expression, sexual orientation, national origin, genetics, disability, age, or veteran status. Cubby Beds is also committed to compliance with all fair employment practices regarding citizenship and immigration status. For data removal requests, visit https://cubbybeds.teamtailor.com/ under “Data & privacy” at the bottom of the page.

This position will remain open until filled.