Quality Engineer, Design Assurance

Early Detection Made Simple™

Denver, CO based BioIntelliSense, Inc., founded in 2018, is an award-winning continuous health monitoring and clinical intelligence company. Our market acceleration and expansion are driven by world-class executive management and a dedicated team of engineers, data scientists, commercial and operational professionals, which collectively harness decades of expertise in virtual care innovations, wearable sensor development, remote connectivity solutions and successful program execution. With these distinctive capabilities and proprietary continuous Remote Patient Monitoring (cRPM) technologies, BioIntelliSense is uniquely poised to transform care delivery from in-hospital to home.

The FDA-cleared and award-winning BioButton® multiparameter wearables, BioHub™ gateways, BioMobile™ downloadable applications, BioCloud™ data services and the BioDashboard™ clinical intelligence system creates a comprehensive tech-enhanced solution that makes continuous monitoring reliable and scalable. Through the platform’s AI-driven analytics, clinicians have access to high-resolution vital sign trending and data-driven insights to enable earlier detection of patient deterioration and proactive intervention for better, safer care.

Join the BioTeam today and create a new standard of continuous care that delivers clinical value, economic benefits and operational efficiencies for providers, patients and caregivers globally! 

We are seeking a Quality Engineer, Design Assurance to join our team and to guidance and hands-on work on BioIntelliSense’s design and development (D&D) process. This position will be working with cross-function teams supporting the new product introduction (NPI) and existing product sustaining processes. This individual will focus on different elements and components of the D&D process including but not limiting to, process creation and optimization, NPI phase gates, risk management activities, cybersecurity risk management, regulatory submissions, and post-market changes. Additionally, this position will support on-going company and Quality Department initiatives as required.

This important position will report directly to the Management Representative and head of Quality. This hybrid position requires being on site (Redwood City, CA) for 2-3 days each week or as often as needed.

What you will be doing

• Conduct product design control activities for NPI and sustaining D&D efforts.
• Establish, maintain, optimize D&D related processes, forms, templates, and tools.
• Serve as Subject Matter Expert in BioIntelliSense design control and risk management SOPs and ensure they meet state-of-the-art regulatory requirements per FDA 21 CFR part 820, ISO 13485:2016, and European EU MDR.
• Provide continuous guidance to other teams and functions to promote complaint and best practice D&D processes; conduct in-person or remote training on relevant subjects, as needed. 
• Take ownership of the quality and consistency of products’ Design History Files (DHF) and, working with Project Management (PM), ensure the proper documentation is being generated and released to support the product development process through the company defined stage gates.
• Provide Quality content review of D&D related deliverable.
• Provide Risk Management oversight per ISO 14971 to establish a product life cycle review process that monitors and reduces product risk from early development through product release to the post-market monitoring stage.
• Responsible for review and approval of project traceability matrices, assuring product requirements can be traced through design input to outputs and finally to verification and / or validation testing. Ensure adequate and timely review and update traceability process to include risk management mitigations to be included.
• Ensure proper product and component critical to quality characteristics are being defined.
• Assist Regulatory FDA 510(k) submissions and other regulatory submissions.
• Working with System Engineering, maintain technical standards and ensure the team is working on the state-of-the-art version of the standards. When needed, interact with third-party test houses that conduct compliance testing.

What you need

• Required:
• Bachelor's or higher degree in engineering, technology or science
• 5+ year’s experience in design control or design assurance functions in medical device company
• Hands-on experience with medical device software (SaMD) and IEC 62305
• Hand-on experience with risk management activities per ISO 14971
• Have strong written and verbal communication skills
• Strong inter-personal skills; Ability to interact with all levels and disciplines of employees
• Organized and able to prioritize duties and responsibilities

 




• Preferred:
• Experience with Cybersecurity risk management is a plus
• Demonstrated initiative, innovation and sound analytical problem solving skills

You'll be excited about this opportunity because you will:

- Join a fast-growing company and grow right along with us

- Work on challenging and interesting tech problems which reshape the future of healthcare

- Get the chance to work on cutting-edge technologies

- Make a large impact across the company through business deliverables and continuous innovation

- Opportunity to build solutions and organizations

Why You'll Love Working at BioIntelliSense

We are leaders - Leadership is not limited to our management team. It's something everyone at BioIntelliSense embraces and embodies.

We are doers - We believe the only way to predict the future is to build it. Creating solutions that will lead BioIntelliSense and healthcare industry is what we do.

We are learning - We're not afraid to dig in and uncover the truth, even when it's inconvenient. Everyone here is continually learning on the job.

We have great benefits - Medical/Dental/Vision/Life, disability (STD & LTD), 401(k) auto contribution program, 11 paid holidays per year, generous paid time off and a weekly lunch perk.

BioIntelliSense is proud to be an equal opportunity employer. All applicants will be considered for employment without attention to race, color, religion, sex, sexual orientation, gender identity, national origin, age, veteran, disability status or any other status protected under federal, state or local law.