Senior Quality Engineer (Software/Cyber)

About Epitel: Epitel empowers clinicians, patients, and caregivers who live with or care for neurological disorders. We’re a venture-backed company funded by top medtech VCs, physicians, hospitals, and strategics. We employ proprietary EEG wearables and powerful AI to create a new platform for brain diagnostics. Our system cuts the time to diagnose brain disorders from hours to minutes and solves critical care access issues. We’re building toward a continuous neurology care platform that will create novel biomarkers for neurological disorders. If you’re interested in a high-impact role at a neurology pioneer, this is it!

Role Mission: This is an exciting role to join Epitel’s growing Quality team as we lean into commercialization. Working directly with our VP of Regulatory and Quality, you will create solutions as part of the Epitel product development and production teams through the application of Quality engineering skills for medical devices. Play an active role from product inception through product launch and maintenance, ensuring that products meet all design control and regulatory requirements. Develop processes to ensure product quality, oversee corrective and preventive actions, identify root causes of problems, and generate solutions.

About the role:

In your first 30 days: Understand the status of the Epitel’s products and QMS, begin overseeing product quality processes

• Complete all relevant QMS training
  1. Become familiar with Epitel personnel operating within the QMS
  2. Review existing gap assessments and work to fill any identified gaps
• Understand the Epitel product (i.e., REMI sensors and tablet hardware, software, and firmware) quality procedures and processes
  1. Complete product training
  2. Understand Epitel’s existing hardware, software, firmware
  3. Understand functional tests required for Epitel product’s Limited Market Release (LMR)
  4. Understand final inspections required for Epitel product’s LMR
  5. Ensure that Device History Records are complete and support final release of LMR Epitel product

In your first 3 months: Support improvements to and operation of the Epitel QMS

• Support implementation efforts for Epitel’s selected electronic QMS
  1. Generate documents to fill gaps identified through a gap assessment of the QMS
  2. Oversee supplier evaluation and control processes, including supplier audits
  3. Track quality metrics and provide reports on quality initiatives

In your first 6 months:

• Provide Quality perspective in product development efforts
  1. Apply IEC 62304 lifecycle principles to software development and testing.
  2. Provide quality perspective to device development and changes, and implement appropriate quality tests.
  3. Provide quality perspective on software issues tracking, automation, issues tracking, risk assessment and bug containment.
  4. Apply quality and risk management perspective to device and company cybersecurity efforts.
• Support department efforts to prepare for MDSAP and achieve MDSAP certification
  1. Respond to any gaps identified through initial outside audits of Epitel’s QMS - in preparation for an MDSAP inspection
  2. Develop procedures, improve processes and policies, and improve practices

In your first 9 months: Ensure successful launches of new products

• Together with the VP, RA/Quality, serve as a lead auditee during an initial MSDAP audit
  1. Lead gap assessment responses following the MDSAP audit
  2. Together with the VP, RA/Quality, serve as a lead auditee in a final MDSAP audit leading to MDSAP certification

Skills/competencies:

• Ethical - for this role, and any of our roles, you must be honest, committed, and have a strong moral compass
• Detail oriented - able to focused, be organized, and able to understand complexity
• Clear communicator - able to simplify challenging topics, persuasive, comfortable working in a team
• Willingness to say no - you must be able to handle confrontation without becoming confrontational
• Willingness to help identify solutions - we are a small team and solutions-oriented, not problem-oriented
• Dedicated to your team - experienced quality leader
• Versed quality practices and policies - track record in device and software development
• Consistently applies technical principles, theories, concepts and quality sciences / tools

Values

1. Act with integrity and assume good intent - We’re as proud of how we’re building as we are of what we’re building. We do the right thing, follow through, and look out for each other. If someone’s stuck, we reach out and help them grind. We’re a team.
2. Give a damn - We do what we do because we’re committed to the cause - working for the next patient, the next caregiver. We listen to patients, their families, their doctors, and build to their needs. We take ownership of that responsibility, our work, and we commit to the mission.
3. Debate ideas, not personalities - Everything we’ve done has been for a reason, but precedent does not equal best practice. We constantly challenge our own ideas while respecting our team’s contributions and competence.
4. Exceptional changemakers - We have to be exceptional - for patients, caregivers, and ourselves. We hold ourselves and each other to the highest standard. We step up to take ownership, leadership, and we follow through. We hire specialists who do the same.
5. Lean into the turn - Healthcare is in constant change. In turn, we constantly accept feedback and change with it. We’re flexible, agile, creative, and we lean into it.
6. Perpetual growth - When you’re creating the next frontier in diagnostics, nobody knows everything. We’re always looking for how we and the company can learn and grow together.
7. We’re serious about our work, not too serious about ourselves - We’re committed to the mission, but your life at work is not your entire life. We have families, friends, pets, hobbies. We want you to bring your whole self to the team and experience your whole self outside of Epitel. That’s why we have regular get togethers, generous vacation, and flexible schedules. The best thing to do with your life is enjoy it.
8. No cloak, no dagger - We’re an open culture. Everybody has the full picture of what’s happening within Epitel. No silos.

Benefits

• Equity - every employee shares in Epitel’s success.
• Professional development allowance - we do better when you do better
• Medical/dental coverage - we pay 100% of premiums
• 401k contribution
• Unlimited vacation - we also take typical US holidays + Pioneer Day (harkening to our Utah roots!)
• Regular IRL meetings - remote work is convenient, but it’s important to get to know one another in-person. We organize time for us to all to be physically in the same place (as long as we’re all safe) every once in a while.