Head - Product Engineering & Operations

• About Ayati Devices

Ayati Devices Pvt. Ltd. is a medical technology company focused on developing innovative medical devices for diabetic foot screening, peripheral neuropathy assessment, vascular assessment, plantar pressure mapping, and microcirculation imaging. Our product portfolio includes VIBRASENSE, VIBRASENSE+T, VASOSENSE, PODOGRAPH, ANGIOCAM, and related solutions.

With products commercialised and deployed across multiple markets, Ayati is strengthening its engineering capabilities to scale product development, improve reliability, standardise technical architecture, and accelerate innovation.

• Role Overview

We are looking for an experienced and technically strong Head – Product Engineering & Operations to oversee engineering implementation, technical architecture, design integrity, and product readiness across Ayati's medical device portfolio.

The role will work closely with the CEO, Product Leads, and cross-functional engineering teams to ensure that product requirements are translated into robust engineering solutions, implementation is technically sound, and products meet defined performance, reliability, safety, manufacturability, and regulatory requirements.

The ideal candidate will have a strong background in electronics, embedded systems, sensors, firmware, and multidisciplinary product development, preferably within the medical device industry.

This is a hands-on technical leadership role requiring the ability to review engineering designs, challenge technical decisions, identify implementation gaps, resolve complex engineering issues, and establish systematic engineering governance across multiple products.

• Key Responsibilities

A. Technical Architecture & Design Reviews

• Review and validate system architecture, technical specifications, electronics, embedded firmware, software interfaces, mechanical integration, and sensor technologies across the product portfolio.
• Evaluate design decisions, technology choices, component selection, interfaces, performance trade-offs, and system-level dependencies.
• Conduct periodic technical design reviews and ensure that engineering decisions are supported by sound technical reasoning and evidence.
• Identify architectural weaknesses, technical debt, scalability limitations, and opportunities for standardisation across products.
• Guide teams in resolving complex technical issues and determining appropriate engineering solutions.

B. Engineering Implementation & Execution Oversight

• Oversee the translation of product requirements and specifications into engineering implementation.
• Review implementation progress across hardware, firmware, software, mechanical engineering, and system integration.
• Challenge assumptions, identify gaps between requirements and implementation, and ensure that critical technical risks are addressed.
• Establish engineering milestones, technical review checkpoints, and objective completion criteria.
• Ensure that engineering changes are evaluated for their impact on product performance, reliability, safety, cost, manufacturing, and regulatory compliance.

C. Verification, Validation & Product Release

• Establish a structured process for design verification, system integration testing, performance testing, reliability testing, and product validation.
• Ensure that product requirements are traceable to design outputs, test protocols, test results, and acceptance criteria.
• Review test plans, test reports, failure analysis, and engineering evidence before major product releases.
• Define technical readiness criteria and recommend whether products or major design changes are ready for release.
• Work closely with Quality Assurance and Regulatory Affairs to ensure appropriate design controls and documentation.
• Ensure that field failures, customer complaints, and recurring technical issues are analysed systematically and translated into corrective and preventive actions.

D. Cross-Product Technology & Platform Development

• Identify common technology platforms, reusable hardware and firmware modules, software components, communication protocols, and development tools across products.
• Standardise engineering practices, interfaces, design guidelines, component selection, and technical documentation.
• Evaluate emerging technologies, components, sensors, actuators, connectivity solutions, and development platforms relevant to Ayati's product roadmap.
• Lead feasibility assessments and technical risk evaluations for new product concepts and major product enhancements.
• Improve product performance, reliability, serviceability, and lifecycle management.

E. Manufacturing & Product Industrialisation

• Work closely with manufacturing, production, procurement, and quality teams to ensure products are designed for manufacturability, assembly, testing, and serviceability.
• Review BOM optimisation, component alternatives, design simplification, and cost-reduction initiatives without compromising product performance or safety.
• Establish manufacturing test procedures, calibration methods, acceptance criteria, and troubleshooting guidelines.
• Support production ramp-up, yield improvement, root-cause analysis, and resolution of recurring manufacturing issues.
• Ensure that engineering changes are properly evaluated and implemented across production.

F. Engineering Governance & Team Leadership

• Establish a consistent engineering review and reporting mechanism across all products.
• Work with Product Leads to review development plans, technical risks, resource requirements, dependencies, and release readiness.
• Mentor engineers and strengthen technical problem-solving, design review, documentation, and testing practices.
• Build a culture of engineering accountability, evidence-based decision-making, and continuous improvement.
• Provide the CEO with concise technical assessments highlighting progress, risks, unresolved issues, critical decisions, and product readiness.
• Escalate significant technical risks, deviations, and delays with clear recommendations and mitigation plans.

G. Quality, Risk & Regulatory Collaboration

• Ensure engineering activities align with applicable medical device quality management and design control requirements.
• Work with Quality and Regulatory teams on risk management, design history documentation, verification evidence, change control, and product lifecycle requirements.
• Support compliance with applicable standards, including ISO 13485, IEC 60601 series, ISO 14971, IEC 62304, IEC 62366-1, and relevant cybersecurity requirements, as applicable to individual products.
• Ensure that product changes are assessed for potential impact on safety, performance, regulatory submissions, and market approvals.

Requirements

• Required Technical Skills & Competencies

• Core technical competencies
• Strong understanding of electronics design, sensors, signal conditioning, instrumentation, and embedded hardware.
• Strong knowledge of embedded firmware development, microcontrollers, peripheral interfaces, communication protocols, debugging, and system integration.
• Experience with hardware-software integration, device connectivity, data acquisition, calibration, and performance optimisation.
• Ability to review PCB designs, schematics, firmware architecture, software interfaces, and system-level design documentation.
• Working knowledge of mobile applications, cloud connectivity, cybersecurity, and data architecture.
• Understanding of mechanical design, product packaging, reliability engineering, and design for manufacturing.
• Strong knowledge of verification and validation methodologies, test engineering, root-cause analysis, and reliability assessment.
• Medical device and quality competencies
• Experience with medical device product development and commercialisation.
• Familiarity with design controls, design verification and validation, risk management, change control, and product lifecycle management.
• Working knowledge of ISO 13485, ISO 14971, IEC 60601, and other relevant medical device standards.
• Ability to work with Quality and Regulatory Affairs teams to establish appropriate technical evidence and documentation.

• Qualifications & Experience

• Bachelor's or Master's degree in Electronics & Communication Engineering, Electrical Engineering, Instrumentation, Biomedical Engineering, Embedded Systems, or a related discipline.
• Approximately 10–15 years of relevant engineering experience, including significant experience in product development and technical leadership.
• Demonstrated experience taking multidisciplinary products from design and development through verification, manufacturing, and commercialisation.
• Experience in medical devices, healthcare instrumentation, diagnostic equipment, industrial electronics, or other safety-critical products is strongly preferred.
• Experience leading cross-functional engineering teams and reviewing technical implementation across multiple products.
• Prior experience in a startup or growth-stage product company, where hands-on execution and structured problem-solving are equally important, will be an advantage.

• Key Performance Indicators (KPIs)

• Performance will be assessed on measurable improvements in engineering quality, execution, and product readiness, including:
• Technical implementation quality: Reduction in design gaps, recurring engineering defects, and avoidable implementation errors.
• Verification and validation: Percentage of critical product requirements supported by completed verification evidence before release.
• Product reliability: Reduction in field failures, repeat complaints, and manufacturing-related technical issues.
• Engineering execution: Adherence to agreed technical milestones and timely resolution of critical engineering dependencies.
• Product release readiness: Completion of technical reviews, risk assessments, verification, and required engineering documentation before release.
• Cross-product standardisation: Adoption of common technology platforms, reusable modules, and standard engineering practices.
• Manufacturing improvement: Improvements in production yield, test coverage, calibration consistency, serviceability, and BOM cost.
• Risk management: Early identification, prioritisation, and mitigation of critical technical risks.
• Team effectiveness: Improved technical capability, engineering accountability, and quality of design reviews.
• Management visibility: Timely, evidence-based reporting of product status, technical risks, and decisions requiring CEO intervention.

• Expected Outcomes in the First 3 Months

• Establish a technical assessment and engineering review process covering all commercialised products.
• Review the architecture, implementation status, technical risks, and lifecycle challenges of each product.
• Identify and prioritise critical gaps in product performance, reliability, design documentation, testing, and manufacturing.
• Implement a standard technical readiness and release review framework.
• Establish product-wise engineering dashboards covering requirements, development, testing, risks, open issues, and release status.
• Identify common technology platforms and opportunities for engineering standardisation.
• Develop a prioritised roadmap for improving engineering quality, product reliability, and development efficiency.
• Reduce the CEO's dependency on direct, day-to-day engineering reviews while maintaining strong technical oversight and decision-making visibility.

• Personal Attributes

• Strong analytical and problem-solving abilities.
• Technically rigorous, detail-oriented, and evidence-driven.
• Comfortable challenging existing engineering decisions constructively.
• Able to understand complex technical details without losing sight of business priorities.
• Strong communication skills, with the ability to explain technical risks and trade-offs to non-technical stakeholders.
• Capable of balancing speed of execution with product quality, safety, and reliability.
• High ownership, accountability, and willingness to get hands-on when required.
• Comfortable working in a fast-growing, multidisciplinary medical technology organisation.