Head of Product Development

Radoratory Technologies; Hyderabad; On-site; INR 4,500,000 - 6,500,000; Full time

Benefits offered by this job

Relocation assistance

ESOP grant

Milestone bonus

Job summary

RADORATORY TECHNOLOGIES seeks a Head of Product Development to own end-to-end product development for three medical devices. You will manage a cross-disciplinary team, drive design-controls, and coordinate with RA/QA to achieve regulatory milestones, including CE/510(k) submissions and Indian registrations.

You will chair design reviews, draft plans, and lead supplier qualification while ensuring alignment with ISO 13485. Onsite work in India with travel to labs and suppliers is expected.

Qualifications

• Experience taking regulated laboratory instruments or medical devices from prototype through verification, validation and design transfer as the lead planner.
• Hands-on experience writing design-control documents: design inputs, design review packages, V&V plans or risk analyses.

Responsibilities

• Chair design reviews and own the design-control system across three devices.
• Lead architecture freeze, design transfer, verification and validation programs.
• Coordinate with RA/QA and external consultants for regulatory submissions and certifications.
• Build, manage and scale a multi-discipline engineering team (mechanics, optics, electronics, firmware, software, ML).
• Develop and maintain an integrated schedule, risk register and decision log.

Skills

Regulated medical device experience

Design controls

ISO 13485 experience

Engineering leadership

Regulatory submissions

Job description

RADORATORY TECHNOLOGIES

Head of Product Development

Scanner, stainer and smear-maker platform for automated blood morphology. Onsite, India. Full time.

The company

Livo is building an automated digital microscopy platform for clinical laboratories, starting with peripheral blood morphology. The system combines a precision slide scanner (sub-100 nm positioning, custom autofocus optics, edge inference on an NVIDIA RTX PRO GPU) with an automated smear maker and stainer and ML-based cell morphology classification. We have working prototypes, blood models near completion, in-house 3-axis and 5-axis precision machining. The next phase is turning prototypes into manufacturable, documented, regulatorily submittable products for India first, then APAC, the US and Europe.

The role

You will own product development end to end: the people, the plan, the design-control system and the delivery of three devices. The founder has run product hands-on until now and is handing it over. You will run a team of 8 to 15 engineers across precision mechanics, optics, electronics and firmware, application software and machine learning, and you will be accountable for the regulatory milestones, delivered with a dedicated RA/QA Manager and external consultants.

This is a hands-on leadership role in a small company. You will chair design reviews, write the plan yourself, qualify a machining supplier, sit in a notified-body audit and present to the board. You will not have a systems-engineering department, a test lab or a documentation group to hand things to; you will build the light versions of those as you go.

What you will do in the first year

• Take the scanner through architecture freeze within 90 days, working with the founder as decider, and then run detailed design, integration, verification and design transfer.
• Take the stainer and smear maker from prototype through design freeze, IEC 61010 and IEC 61326 testing, transport qualification, pilot build and Indian registration, with EU Class A documentation ready to release.
• Stand up design controls across all three devices: design and development plans, design inputs, risk management files under ISO 14971, traceability, design reviews with minutes, and a design history file structure that survives audit.
• Own the plan: one integrated schedule across three devices with the critical path, long-lead procurement, a risk register and a decision log; a weekly program review; a monthly one-page dashboard for the board.
• Get the scanner's clinical performance study running: protocol aligned to CLSI H20-A2 and ICES guidance, agreed with pathologist KOLs and RA/QA; CDSCO test license and performance-evaluation permission; ethics approvals; sites enrolling.
• Lock the US strategy with RA/QA: predicate analysis, FDA pre-submission, model change-control plan, cybersecurity file.
• Support ISO 13485 certification with the RA/QA Manager and shortlist a notified body for the scanner's IVDR Class B assessment.
• Complete productization for the first two devices: IFU and labeling, UDI, packaging and transport testing, service manual, training material, manufacturing work instructions and incoming inspection for precision parts.
• Build the team: hire a technical writer and a test engineer early, define ownership for every work package, and run the engineering group so that the founder's time in product falls below ten percent within nine months.

What you bring

Required

• You have taken at least one regulated laboratory instrument or medical device from prototype through verification, validation and design transfer as the person responsible for the plan.
• You have personally written design-control documents: design inputs, design review packages, V&V plans or risk analyses. We will ask to see one, redacted.
• You have managed six or more engineers across at least three disciplines with hardware in the mix.
• You have worked inside an ISO 13485 quality system and been audited in it.
• You have been a core contributor to at least one submission: 510(k), CE technical file, CDSCO licence or equivalent.
• You can chair a design review on motion control, optics or precision mechanics and tell when the engineer is hand-waving.
• You write clearly. A writing sample is part of the process.
• You will work onsite at Livo in India full time, with travel to suppliers, test labs and clinical sites.

Preferred

• Hematology, digital morphology, microscopy or digital pathology instruments.
• Experience working alongside an ML or image-analysis group: dataset versioning, model freeze, locked-algorithm verification.
• IEC 62304 Class B or C software documentation and a cybersecurity file.
• Design transfer of a precision optomechanical assembly, including supplier qualification of machined parts and optics.
• A notified-body audit or FDA inspection as a named responsible person.
• Two or more years in a startup or small company at some point in your career.
• APAC filings exposure through distributors or in-country representatives.

How we will work together

You report to the founder and CEO, who keeps product vision, roadmap, claims, pricing and customer relationships, and who decides the scanner architecture freeze once. After that, design changes run through your change-control process and the CEO attends phase-gate reviews and a monthly program review. Decision rights are written down before you start and shared with the team. The RA/QA Manager reports to the CEO for independence and works with you daily. The ML lead owns research direction; you own what ships.

Compensation

Fixed cash in the senior-manager to director band for Indian medtech, a milestone bonus tied to four dated outcomes (first Indian registration + CE, clinical study first site enrolling, FDA), and a meaningful ESOP grant with a four-year vest, one-year cliff. Relocation assistance available.

Process

A 30-minute screen with the founder; a career-history interview; two technical panels (mechanics and optics; software and ML); a paid take-home planning exercise on our real program; conversations with three engineers on the team; references, which the founder calls personally; offer.