Samd Regulatory Jobs in Wisconsin (NOW HIRING)

Hi, I'm Will, an Engineering Manager at EnsoData! We're excited to announce that we're looking for a new teammate - an experienced backend engineer passionate about making healthcare better. This position offers a salary of $130,000-$140,000 along with bonus program, stock options, and benefits, including paid time off and health insurance.
As a Backend Engineer at EnsoData, you will take full ownership of our core backend infrastructure, including the API and data processing pipelines. You are responsible for the end-to-end lifecycle; you will design, develop, test, deploy, and maintain critical services supporting the EnsoSleep application. A primary focus of this role is ensuring our backend systems are architected for scalability and security while maintaining strict adherence to SaMD regulatory standards, including FDA, HIPAA, and ISO 13485.
On a given day, this could include:

• Core backend development & architecture - architect and scale solutions, owning end-to-end SDLC, and more.
• Interoperability & problem solving - build and maintain EnsoData's interoperability interface, partner with other team members to investigate root cause analysis, deploy reliable technical solutions for customers.
• Quality & engineering excellence - testing and automation, code review and technical documentation.
• Regulatory & compliance (SaMD) - regulatory adherence, QMS integration and cross function collaboration.

About EnsoData
EnsoData strives to make healthcare more accurate, efficient, and affordable through waveform artificial intelligence (AI) technology. Using AI and machine learning, our software analyzes billions of data points collected from sensors placed throughout the human body. Our first solution, EnsoSleep, reduces the time clinicians spend analyzing, scoring and managing sleep studies. This results in a simplified and accelerated patient testing, diagnosis, and treatment workflow. Our AI-powered technology has the capability of informing health decisions beyond sleep medicine, from monitoring patient health in the ICU or through wearables, to detecting and capturing seizure data, to providing earlier detection of heart disease, diabetes, stroke, and Alzheimer's.
Here is a little about what we are doing in the world of sleep medicine...
EnsoHST- FDA-Cleared, AI-Powered Sleep Diagnosis Using Pulse Oximeters
EnsoSleep - FDA-Cleared PSG and HSAT Scoring and Study Management
**Here is a link to learn a little about our Celeste app!
Requirements

• Bachelor's or Master's degree in Computer Science, Software Engineering, or a related technical field.
• 3+ years of backend engineering experience, ideally within a startup or high-growth software environment.
• Strong proficiency in Python, Go, or Java (Python preferred), with a track record of building and maintaining scalable RESTful APIs and microservices.
• Demonstrated expertise in data modeling and database design using both relational (e.g., PostgreSQL) and NoSQL (e.g., MongoDB) systems.
• Practical experience deploying and managing applications on cloud platforms (AWS, GCP, or Azure) using Docker,Kubernetes, and CI/CD pipelines.
• Proficient in Git and experienced in working within a collaborative production codebase.
• Deep understanding of data privacy standards (e.g., HIPAA, GDPR) and a commitment to implementing secure application development practices.
• Excellent troubleshooting skills with the ability to investigate and resolve complex root-cause issues in a timely manner.
• A mission-driven mindset with the integrity and perseverance required to build technology that improves healthcare efficiency and affordability.

Preferred Experience

• Experience with HL7, FHIR, DICOM, or other healthcare interoperability standards.
• Experience with Claude (or comparable agentic AI tools) for development; including code generation, architectural guidelines and workflow optimization.
• Knowledge of medical device regulations (FDA Class II/III, EU MDR).
• Understanding of software risk management, validation, and clinical workflow integration.
• Familiarity with Agile methodologies and DevOps culture.
• Contributions to open-source software is a plus.

We will give preference to candidates who are local to Wisconsin and/or the Midwest US.
Company Culture - Embrace the Pineapple!

• Make Healthcare Better - passionate about improving healthcare experiences.
• Put Customers First - dedicated to understanding and meeting customer needs.
• Be a Great Teammate - foster a collaborative and supportive work environment.
• Gets $#!t Done - act decisively and go above and beyond.
• Inject a Focus on Quality - maintain integrity and attention to detail in all aspects of work.

Benefits
The benefits package includes, but is not limited to, the following:
Remote and flexible schedule - we are a remote company with hybrid options and support for flexible schedules! That being said, we have an amazing office headquarters in downtown Madison, WI with views of the capitol that you are welcome to work at anytime. In case you didn't know, Madison has consistently been ranked as one of the top places to live in the US (businessinsider.com, money.com, livability.com)!
Health, dental, and vision insurance with options to choose a plan that fits you and your dependents needs.
Paid time off options - we want our employees to rest, recharge, and feel better.
Stock options - we want team members to feel ownership in the organization. When EnsoData does well, you do well.
Company Bonus Program - if we do well, we want to reward our team members! This position may include participation in the company bonus program.
401k to help people invest in the future.
Team Summits! We look forward to opportunities to gather in person and enjoy a few days together. We participate in team events and gain some great in-person time. (Hint: check out our blog for info from former team gatherings!)
Interview Process

1. Submit a resume online and our hiring team will choose those that seem like the best candidates.
2. We look forward to meeting you face-to-face! A few candidates will be chosen for a video call to get to know each other, discuss your experience, and explain the position in more detail.
3. Expect an opportunity to show your skills.
4. The final candidates will have a chance to meet a few people from the team.
5. Offer!

Let's talk
EnsoData seeks to recruit, hire, and retain the most talented people from a diverse candidate pool. Research shows that while men apply to jobs when they meet an average of 60% of the criteria, women and other marginalized folks tend to only apply when they check every box. If you think you're a great fit, but don't necessarily check every box on the job description, please still get in touch.
To learn more about our ongoing commitment to diversity, see our updated website here.
Note: this role is based in the continental United States and currently EnsoData is unable to support sponsorships so candidates must be legally eligible to work and reside in the United States now and in the future.
Equal Employment Opportunity
EnsoData is proud to be an Equal Employment Opportunity employer. We do not discriminate against, nor do we tolerate unlawful harassment against, team members or any other covered persons on any basis of race, color, protective hairstyles, national, social, or ethnic origin, gender, pregnancy, childbirth, gender orientation, identity or expression, sexual, relationship, or romantic orientation, marital, civil union or domestic partnership status, family or parental status, age, protected veteran status, arrest record, expunged or sealed convictions, criminal history, source of income, credit history, housing status, physical, mental, or sensory disability, medical condition, genetic information, religion, or any other status protected by the laws or regulations in the locations where we operate.
We value, celebrate, and support diversity, inclusion, and our differences. We are committed to providing a safe work environment and a company culture of mutual respect where equal employment opportunities are available to all applicants and teammates. We seek to recruit, hire, and retain the most talented people from a diverse candidate pool. We strongly encourage women, people of color, LGBTQIA+ individuals, people with disabilities, members of ethnic minorities, intersectional individuals, foreign-born residents, and veterans to apply. We have a deep conviction that diversity and inclusion among our teams, our communities, and our physical and virtual workplaces is vital to the success of EnsoData's mission to improve healthcare access, outcomes, and affordability for patients and communities everywhere.
If you are a job seeker applying to EnsoData and you feel that you need to request an accommodation or alternative application, please contact Angela at angela@ensodata.com.