Manager Medical Device Software Engineer Jobs in Indiana

Job Title:

Director, Market Development (Software as a Medical Device (SaMD)

Reporting to:

VP/GM of Software

Location:

San Diego (West), Indianapolis (Central), or Boston (East)

Job Site:

Hybrid; remote considered for the right candidate, with travel

Job Description Revision Date:

August 18, 2026

Since 1997, The RND Group has built the software inside the instruments our clients take to market — analyzers, sequencers, and point-of-care systems where the software is part of the regulated device and carries the FDA submission with it. That instrument legacy is the core of what we sell and the credential this role leverages to grow. The same discipline now extends into medical device cybersecurity, connected diagnostics, and Software as a Medical Device. Now part of Gener8 — a premier engineering and manufacturing partner with a global footprint — we help life science and medical device innovators bring complex products to market.

This is a hunting role. We are looking for a Director of Business Development to grow our software engineering business across medical devices, diagnostics, and life sciences — starting from the instrument work that built this company.

You will own the front end of the funnel: finding the companies with a product development roadmap we can serve, getting into the room long before an RFP exists, and earning the technical credibility to shape what gets scoped. Our buyers are CTOs, VPs of R&D, and program leaders who have been burned by vendors that did not understand IEC 62304. You need to be the person in the meeting who does.

You will own the software growth number and the plan behind it — which segments we pursue, which offerings we lead with, and how we show up in the market. Real strategic latitude, not a seat that executes someone else's territory plan.

What this is not: an account management seat waiting on inbound leads.

This is the bag you will carry. Instrument software is our core and our credential; everything else has grown out of it:

• Instrument and embedded software — our core. Control software, user interfaces, connectivity, and data handling for analyzers, sequencers, and point-of-care systems: software in the medical device, shipping as part of the regulated product. Our deepest bench, and the strongest reference base you will sell from.
• Full-lifecycle regulated development. Requirements, architecture, implementation, verification and validation, and submission-ready documentation under IEC 62304 and design controls.
• Productized IP that shortens the runway. Our Application Accelerator — a pre-validated starter framework with architecture and documentation already verified — gives a regulated program a running start and takes real cost out of verification. Our LIS Connector pairs a tested lab information system connectivity component with the integration and validation services around it.
• Medical device cybersecurity. Threat modeling, secure architecture, SBOM generation and management, vulnerability and patch management, penetration testing, and the premarket documentation required for cyber devices under Section 524B of the FD&C Act.
• Cloud, data, and connected diagnostics. Regulated cloud architectures, data pipelines, and the platforms that put instrument data to work.
• Software as a Medical Device (SaMD). An adjacent extension of the same regulated discipline, for clients whose product is the software itself.
• Remediation and modernization. Legacy system rescue, audit and inspection response, and bringing inherited software into compliance.

• Own the plan and the number. Build the software growth strategy and carry the revenue number against it. You will set direction with the VP/GM rather than receive it, and you will pull delivery, marketing, and engineering into your pursuits without owning them on an org chart.
• Lead with the instrument legacy. Nearly three decades of shipped instrument software is your opening credential — use it. Get in on the strength of work we have already delivered, then widen the conversation into connectivity, cybersecurity, and SaMD as the roadmap calls for it.
• Hunt. Build and work a pipeline of net-new targets — instrument OEMs, established device manufacturers, and emerging biotech and diagnostics companies. Prospect deliberately, not opportunistically.
• Probe the roadmap. Get clients talking about what they are building 12–24 months out. Identify where instrument software, connectivity, cybersecurity, and regulated SDLC work will be needed — and position RND before the requirement is written.
• Sell across the full SDLC. Speak credibly to requirements, architecture, verification and validation, design controls, and submission-ready documentation. Know enough to scope a project, and know when to bring an engineer.
• Own the commercial lifecycle. Qualification, technical discovery, proposal scoping and writing, pricing strategy, negotiation, and close — then convert first projects into multi-year programs by staying close to client technical leadership. Meet and exceed software revenue targets.
• Be visible where innovation happens. Trade shows, academic symposiums, startup incubators, VC networks, and industry consortia. Come back with names and next steps, not brochures.

• A track record of winning new business. Proven, quota-carrying success selling software development or engineering services consultatively. You can point to logos you personally opened.
• Experience. 10+ years in the software development or engineering services industry, including 4+ years in a client-facing business development, sales engineering, or capture role.
• Instrument and device domain credibility. You have sold into, or delivered for, medical device or diagnostics companies building instruments, and can talk about embedded and connected device software without a script.
• Regulated-environment fluency. Working command of FDA 21 CFR Part 820 / QMSR, ISO 13485, ISO 14971, and IEC 62304 — and what each means for cost, schedule, and risk in a software program.
• Technical foundation. BS or MS in Computer Engineering, Computer Science, or a related technical field preferred; equivalent hands-on technical experience considered. An MBA is a plus.
• Hunter instincts, high EQ. Comfortable with cold outreach and long sales cycles, and equally comfortable advising a CTO. You build partnerships, not transactions.
• Self-direction. Competitive, organized, and able to run a territory and a growth plan without being managed to it.
• Travel. Approximately 25%, with more possible depending on territory, client needs, and the event calendar.

Competitive base salary plus participation in a performance-based bonus program tied to business development results. Full benefits, and the backing of Gener8’s global engineering and manufacturing footprint behind every proposal you write. Incentive plan details are reviewed during the interview process.

We operate at the intersection of cool science and precision engineering — the software we build ends up inside the instruments that diagnose disease and guide treatment. Our culture: high autonomy, intellectual rigor, and a healthy dose of wit. We work hard because the software we build matters.

Company Benefits: