Job Title:Manager, Market Development (Software as a Medical Device (SaMD)Reporting to:VP/GM of SoftwareLocation:San Diego (West), Indianapolis (Central), or Boston (East)Job Site:Hybrid; remote considered for the right candidate, with travelJob Description Revision Date:August 17, 2026The RoleThis is a hunting role. We are looking for a Business Development Manager to open new doors and grow our software engineering business across life sciences, diagnostics, and medical devices.
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.
What this is not: an account management seat waiting on inbound leads.
What We SellThis is the bag you will carry. Our offering has broadened well past classic instrument software:
- Full-lifecycle regulated software 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. Reusable IP you lead with - it changes the schedule conversation before price comes up.
- Software as a Medical Device (SaMD). Standalone clinical software - from IMDRF risk categorization through 510(k) and De Novo support, including AI/ML-enabled device software functions and predetermined change control plans.
- 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.
- Instrument, embedded, and connectivity software. Control software, interfaces, and device connectivity for analyzers, sequencers, and point-of-care systems.
- Cloud, data, and platform engineering. Regulated cloud architectures, data pipelines, and connected-diagnostics infrastructure.
- Remediation and modernization. Legacy system rescue, audit and inspection response, and bringing inherited software into compliance.
What You'll Do- Hunt. Build and work a pipeline of net-new targets - emerging biotech and diagnostics companies, established device manufacturers, and instrument OEMs. Prospect deliberately, not opportunistically.
- Probe the roadmap. Get clients talking about what they are building 12-24 months out. Identify where instrument software, connectivity, data platforms, cloud, 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.
- Open the newer offerings. SaMD and cybersecurity are where our capability has outrun our market awareness. Take our SaMD experience into clinical software and AI-enabled device companies, and take our cybersecurity practice into the installed base now facing Section 524B expectations. Every legacy device on the market is a cybersecurity conversation waiting to happen.
- Own the commercial lifecycle. Qualification, technical discovery, proposal scoping and writing, pricing strategy, negotiation, and close. 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.
- Land and expand. Convert first projects into multi-year programs by staying close to client technical leadership and anticipating the next phase of their roadmap.
What You Bring- Evidence you can create opportunity. Quota-carrying business development experience is ideal. We will also look hard at sales engineers, technical pre-sales, inside sales, and project or program managers ready to move client-side. What matters is proof you have opened something, not just serviced it.
- Experience. 5-10 years in the software development or engineering services industry, including 2+ years in a client-facing business development, sales engineering, or capture role.
- Regulated-environment exposure. Familiarity with FDA 21 CFR Part 820 / QMSR, ISO 13485, and IEC 62304 - or a demonstrated ability to come up the curve quickly in a technically demanding, regulated domain.
- Appetite for SaMD and cybersecurity. Curiosity about what Software as a Medical Device (SaMD) and medical device cybersecurity mean commercially. We will teach you the regulatory detail and put an engineer beside you; you bring the instinct for where the opportunity is.
- Technical foundation. BS in Computer Engineering, Computer Science, or a related technical field preferred; equivalent hands-on technical experience considered.
- Hunter instincts, high EQ. Comfortable with cold outreach and long sales cycles, and comfortable holding your own in a room with a CTO. You build partnerships, not transactions.
- Drive and coachability. Competitive and self-directed, with the humility to learn a complex regulated market quickly.
- Travel. 25-40% to clients, trade shows, and other Gener8 sites.
What We OfferCompetitive base salary plus a performance-based incentive tied directly to what you bring in. Full benefits, and the backing of Gener8's global engineering and manufacturing footprint behind every proposal you write.
Company Benefits:
Health, Dental and Vision insurance; 401(k); Life insurance; STD, LTD; Flexible spending account, Health savings account; Paid time off; Employee discounts, Referral program
