Operations Manager

Connecticut Innovations, Inc.; New Haven (CT); Vor Ort; USD 120.000 - 165.000; Vollzeit

Zusammenfassung

Oivi is expanding its US operations from New Haven, CT, and seeks an operations leader to own HIPAA/compliance, logistics and commercial support for US deployments.

You will work with the CEO and commercial team, scale processes with tooling and automation, and tailor the role to your strengths while growing the business footprint across clinics.

Qualifikationen

• Operations experience in medtech, digital health, healthcare or regulated industry.
• Exposure to HIPAA; medical device QMS, FDA or ISO 13485 is a strong plus.
• Some exposure to information security in regulated/healthcare settings; coordinate with CTO.
• Supply chain, logistics and inventory experience including customs and import.
• Comfortable with legal text and working alongside counsel; not necessarily a lawyer.
• Builder's instinct for process, best practices, and automation.
• Authorized to work in the US; some travel to Oslo and Bangalore teams.

Aufgaben

• Own the operational backbone of Oivi's US business across legal/compliance, logistics, and commercial support.
• Build on existing US operations to scale with standards, processes and tooling.
• Collaborate with CEO and commercial team; ensure deployments pass through this role.
• Shape the role around strengths in one area and curiosity in others.
• Match scope and title to experience if needed.

Kenntnisse

Operations experience

HIPAA exposure

Information security exposure

Supply chain logistics

Regulatory/compliance coordination

Automation tools interest

Jobbeschreibung

Are you ready to join Connecticut Innovation’s vibrant community of innovators? Connecticut Innovations (“CI”) is Connecticut’s strategic venture capital arm, and we are passionate about serving our portfolio of 220+ companies across various industries, with strengths in life sciences, technology, and climate tech.

We are an investor in Home | Oivi!

About Oivi

Oivi brings the diabetic eye exam into the primary care visit. About 90 seconds at the camera and a graded report back within 15 minutes, so the practice captures the patient's annual diabetic eye exam in the same visit. No dilation, no darkroom and no extra visit. The patients who need an ophthalmologist are the ones who get referred to one.

Founded in 2017, we are around 40 people across Norway, the United States, India and China. More than 200,000 patients have been screened on our technology to date, across US primary care and screening centers in Asia.

We are also working beyond diabetic eye disease: cardiovascular risk from the same retinal image with Fujifilm, where over 100,000 patients have been screened with paired cardiac CT and retinal images, and we are starting dementia research alongside well-known academic and clinical institutions in Europe and the United States.

• We are live, not pre-market - our camera is FDA registered and 510(k) exempt as a general-use ophthalmic camera, so it is commercially available and in clinics across the US today. Whoever joins is selling, deploying and supporting a product that is already in the market and already generating revenue, not waiting for a regulatory gate to open.
• Fast growing - our target is thousands of cameras in the market through 2027 and into 2028. The US is the engine of that growth, and these three New Haven hires are an important part of the team that delivers it. The room to grow into is large. There are more than 120,000 primary care locations in the United States, the diabetic population keeps rising, and roughly half of those patients still miss their annual eye exam. Every one of them is a candidate for screening inside a visit they are already attending.
• Our investor base is a mix of angels, venture capital funds, institutions and professional investors.

The Role

Own the operational backbone of Oivi's US business across three areas: legal and compliance, logistics and inventory, and commercial support for US deployments.

You are not starting from a blank page. We already run this business in the US: customers live, devices in clinics, contracts signed, HIPAA and our quality system in place. The job is to build on that foundation and make it scale, setting the standards, processes and ways of working that let us move faster and handle more. We care about doing that with good tooling rather than more headcount, so if you are interested in automation, AI and technology as a way to make operations scale, there is real room to use it here.

You report to our CEO and you work side by side with the commercial team every day. Nothing we sell reaches a clinic without passing through this role, so that relationship is the one that makes or breaks it.

The three areas are not equally weighted for everyone. If you are strongest in one of them and genuinely curious about the others, say so. We would rather shape the role around a strong person than hold out for someone equally expert in all three.

We have scoped and titled this at manager level. If the right person arrives with more experience than that, we will match the scope and the title to them rather than lose them over a word.

Legal & Compliance

• Own and extend how we operationalize HIPAA across tools, vendors and internal processes.
• Work with external counsel on customer contracts, BAAs, DPAs and intercompany agreements.
• Translate contract terms into SLAs and processes the team can actually run, then track performance against them.
• Support FDA and medical device QMS activities operationally, covering documentation flow, traceability and change control, and prepare for customer and QMS audits.
• Take over the day to day of customer security reviews and questionnaires alongside our CTO and engineering team. We do this today; the point of the role is to run it faster and at higher volume without pulling engineering off the product.
• Keep our information security practice running as we scale: vendor and subprocessor reviews, access management, the incident response process, and the evidence behind it.
• Own and scale US inventory: levels, locations, safety stock and serial tracking for devices, spares and accessories.
• Own inbound and outbound shipments, customs and import documentation, and the carrier and 3PL relationships.
• Manage the RMA and repair loop with Support and Engineering.
• Watch lead times and stock-outs, and propose reorder points and alternatives before they bite.
• Own deployment readiness so hardware, software, credentials, training materials and documentation are in place before a clinic goes live.
• Coordinate clinic onboarding logistics and training, on-site and remote, with the commercial team.
• Make sure what is sold can be delivered on the timeline promised.
• Standardize, digitalize and automate the core processes as volume grows.

About You

You do not need to tick every box below. If several of these describe you and the role appeals, we want to hear from you.

• Operations experience in medtech, digital health, healthcare or another regulated industry.
• Practical exposure to HIPAA. Medical device QMS, FDA or ISO 13485 is a strong plus.
• Some exposure to information security in a regulated or healthcare setting, for example running customer security questionnaires, SOC 2 or HITRUST work. You coordinate this with our CTO rather than own it technically.
• Supply chain, logistics and inventory experience including customs and import.
• Comfortable with legal text and working alongside counsel. You do not need to be a lawyer.
• A builder's instinct for process and best practice, and an appetite for tooling and automation rather than manual patchwork.
• Authorized to work in the US. Some travel, including to our Oslo and Bangalore teams.
• Lawyers moving into operations are welcome.

Why Connecticut

Oivi's US headquarters is in transition to New Haven, Connecticut, at District New Haven, 470 James Street. We have been selling, deploying and supporting customers in the US since our first pilot in 2024. New Haven is where we take that from working to scaling.

New Haven sits in the middle of the New Jersey to New York to Boston corridor: the densest concentration of primary care practices, community health centers and health systems anywhere in the country, and an enormous patient population. Most of the accounts our Connecticut team will work sit within a two and a half hour drive. We are also next door to one of the strongest academic medical clusters in the United States.

This is a commitment, not a test. Connecticut headcount goes to four this round, including our CEO. As the US business scales we expect to add a further eight to ten Connecticut roles through 2028.

How We Work

It is fun to work here. It is also demanding. We are a small team carrying a large ambition, and everyone sits close to the outcome. That is what makes the work rewarding and what makes it challenging, usually in the same week.

There is a lot of drive in this team and a lot of passion for what we are building. We do not hire the same personality over and over. We look for people who complement each other, who bring something the rest of us do not have, and who are comfortable saying so.

None of these roles sits alone in Connecticut. We work as one team across Norway, the United States, India and China, and the New Haven hires are wired into that from the first week.

It goes both ways. You will lean on colleagues in engineering, product, quality and clinical wherever they sit, and they will lean on you. What we learn in US clinics shapes what gets built, and what is built elsewhere lands in your hands. In practice that means some early calls and some late ones, and it also means a much larger team behind you than the people sitting in New Haven.

Oivi is proud to be an equal opportunity employer. We are committed to building a diverse and inclusive team and do not discriminate on the basis of race, color, religion, sex, including pregnancy, childbirth, or related medical conditions, sexual orientation, gender identity or expression, age, national origin, disability, genetic information, marital status, veteran status, or any other characteristic protected by applicable federal, state, or local law.

We encourage candidates of all backgrounds to apply, and we provide reasonable accommodations during the hiring process for individuals with disabilities, upon request.