Head – Product Engineering & Operations

Pacify Medical Technologies Pvt Ltd; Mumbai; In loco; INR 3.500.000 - 6.000.000; Tempo pieno

Descrizione del lavoro

Pacify Medical Technologies Pvt Ltd seeks a highly experienced Head – Product Engineering & Operations to oversee engineering implementation, architecture, design integrity, and product readiness across the Pacify portfolio.

The role requires a strong background in mechanical and electro-mechanical systems, with multidisciplinary product development and a track record of leading cross-functional teams in the medical device space.

Competenze

• Strong background in mechanical, electro-mechanical systems, and multidisciplinary product development.
• Experience leading cross-functional engineering teams across multiple products.
• Familiarity with medical device quality standards (ISO 13485, IEC 60601) and design controls.
• Startup or growth-stage environment with hands-on execution is advantageous.

Mansioni

• Oversee engineering implementation, technical architecture, design integrity and product readiness across Pacify's portfolio.
• Lead engineering reviews, governance and decision-making across hardware, firmware, software and manufacturing.
• Collaborate with Q&R teams to ensure regulatory compliance and risk management.
• Drive standardisation across products and platforms, and ensure manufacturability and serviceability.

Conoscenze

Mechanical engineering

Electronics design

Sensors integration

Embedded firmware

System architecture

Product development leadership

ISO 13485 knowledge

ISO 14971 / IEC 60601 awareness

Design controls

Cross-functional leadership

Formazione

Bachelor's or Master's in Mechanical Engineering

Descrizione del lavoro

Pacify Medical Technologies Pvt Ltd focuses on solving real healthcare challenges using innovative technology combined with deep empathy for patients and care teams. The organization is driven by a mission to help people recover faster and improve overall quality of life. Team members collaborate across disciplines to design and deliver practical, impactful medical solutions.

2. 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 Pacify Medical portfolio.

The role will work closely with the CEO, 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 mechanical, electro-mechanical systems, 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.

3. Key Responsibilities

A. Technical Architecture & Design Reviews

• Review and validate system architecture, technical specifications, mechanical. 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.
• 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 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 Pacify's product roadmap.
• Improve product performance, reliability, serviceability, and lifecycle management.
• 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.
• 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.
• 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.

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

4. Required Technical Skills & Competencies

Core technical competencies

• Strong understanding of mechanical engineering design, electronics design, sensors, and embedded hardware.
• Ability to review PCB designs, schematics, firmware architecture, software interfaces, and system-level design documentation.
• 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.

5. Qualifications & Experience

• Bachelor's or Master's degree in Mechanical Engineering or a related discipline.
• Approximately 10 –15 years of relevant engineering experience, including significant experience in product development through verification, manufacturing, commercialisation and technical leadership.
• 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.

6. 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.

7. Expected Outcomes in the First 3 Months

• Establish a technical assessment and engineering review process covering all products.
• Identify and prioritise critical gaps in product performance, reliability, design documentation, testing, and manufacturing.
• Implement a standard technical readiness and release review framework.
• Reduce the CEO's dependency on direct, day‑to‑day engineering reviews while maintaining strong technical oversight and decision‑making visibility.

8. Personal Attributes

• Technically rigorous, detail‑oriented, and evidence‑driven.
• Comfortable challenging existing engineering decisions constructively.
• Capable of balancing speed of execution with product quality, safety, and reliability.
• High ownership, accountability, and willingness to get hands‑on when required.