Manager, Market Development (Software)

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 (SaMD). 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 Business Development Manager to open new doors for 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 report to the VP/GM of Software and work shoulder to shoulder with our engineering leads. You are expected to open doors and build pipeline on your own; you will not be sent into a technical conversation alone.

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.

• 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.
• Lead with the instrument legacy.Nearly three decades of shipped instrument software is your opening credential use it. Get into diagnostics and device companies on the strength of work we have already delivered.
• Own your pipeline and your number.Carry a quota against the software growth plan keep your pipeline honest and current and work with the VP/GM to decide where your time is best spent.
• Probe the roadmap.Get clients talking about what they are building 1224 months out and flag where instrument software connectivity cybersecurity or regulated SDLC work will be needed.
• Get fluent across the SDLC.Learn to speak credibly to requirements architecture verification and validation design controls and submission-ready documentation enough to qualify an opportunity and know which engineer to bring.
• Run the commercial process.Qualification technical discovery and proposal scoping and writing with support from delivery and leadership on pricing and negotiation.
• Show up where innovation happens.Trade shows academic symposiums startup incubators and industry events. Come back with names and next steps not brochures.

• 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.510 years in the software development or engineering services industry including 2 years in a client-facing business development sales engineering or capture role.
• Instrument or device exposure.Time spent around medical device diagnostics or instrumentation companies or a clear appetite to learn that world quickly.
• 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.
• 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.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 Gener8s 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:

Health Dental and Vision insurance; 401(k); Life insurance; STD LTD; Flexible spending account Health savings account; Paid time off; Employee discounts Referral program