Head of electrical engineering

Purpose of the Role:
The Head of Electrical Engineering will act as the head of electrical R&D and the business process owner for Olympus’s Standard Operating Procedures related to product development (e.g,. Design Controls, Verification, Validation, Design & Development Planning, User & Product Requirements, Administer and obtain Requirements tools, Etc.), and function as a steward of our product development processes.
The ideal candidate shall be a hands-on technical leader with extensive experience in developing medical devices and systems. The individual will be responsible for setting up the engineering R&D function for global scope of work and own the execution of engineering projects, ensuring alignment with Olympus’ global R&D strategy. This role is responsible for driving the engineering R&D scope of work, focusing on leading engineering teams and project delivery in collaboration with the Olympus’ global R&D and India leaders. The incumbent will spearhead project planning, budget management, and technical oversight, ensuring seamless coordination across teams to meet project timelines and deliverables with minimal operational input from Olympus HQ.
On the technical front, this role will provide strategic oversight to the center while ensuring high-quality engineering outcomes in the development of medical devices. By leading electrical engineering initiatives, this individual will guide the design, verification, and validation processes, ensuring compliance with regulatory standards such as FDA Design Controls. The position demands a strong mix of technical proficiency and proactive project leadership, fostering a collaborative environment that aligns the electrical R&D performance with Olympus’ offshore vision.
Key Responsibilities:
Functional Setup:
Lead the functional setup and management of the electrical function, optimizing workflows, task assignment, hiring/team set-up and resource management
Seek to ideate enhancements to systems and processes with the goal of increasing product development efficiency, communication, and/or quality
Collaborate with global PMO teams to ensure the engineering R&D function growth roadmap is aligned with Olympus’ long-term R&D strategy and technical priorities
Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus’ technical standards
Work closely with the PMO to manage demand planning and resource forecasting for the function, ensuring sufficient talent and infrastructure for current and future electrical projects
Implement continuous improvement initiatives within the electrical engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams
Identify and implement cutting-edge technologies and engineering practices to improve product performance and drive innovation
Participate in strategic planning and provide technical insights to support long-term growth and competitiveness
Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance
Create systems to ensure all updates/changes are communicated across sites/employees
NPD and Stakeholder Management:
Head the electrical engineering function to own and account for the delivery, execution and management of all NPD activities within the India scope of electrical engineering
Provide strategic oversight and guidance for electrical R&D projects, ensuring external and internal teams align with performance specifications, regulatory standards, and Olympus’ overall R&D objectives
Oversee the design and development of electrical systems, including circuit design, PCB layout, power management, and signal processing for medical devices
Ensure designs are optimized for safety, reliability, manufacturability, and compliance with medical device standards
Manage the selection and integration of components, sensors, and electronic systems that meet design requirements and regulatory standards
Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations
Act as the subject matter expert on design control for electrical R&D, provide guidance to product development teams (both internal and external)
Ensure that design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders
Drive the development of IP strategies by working with PMO and legal teams, ensuring vendor partner adhere to Olympus’ requirements for protecting intellectual property in product designs
Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays
Project Management:
Head the Engineering R&D function to serve as the strategic interface between global PMO and vendor partner, providing updates on technical progress, risks, and issues while ensuring alignment with the overall R&D strategy
Develop and manage technical roadmaps with input from vendor partner, ensuring timelines, milestones, and resource planning are optimized for the electrical R&D function
Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed
Manage and oversee the maintenance of technical RAID logs, working with vendor partner to ensure risks are identified, escalated, and addressed promptly
Oversee coordination between vendor partner and software development teams to ensure seamless integration of electrical designs into broader product architectures
Ensure adherence to Olympus’ design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability
Provide high-level guidance on the verification and validation testing strategies proposed, ensuring they meet Olympus’ quality and performance specifications
Regulatory & Compliance:
Ensure that electrical designs meet relevant regulatory standards (IEC 60601, ISO 13485, FDA 21 CFR Part 820) and safety standards (UL, CE)
Lead risk management activities, including electrical safety analysis, electromagnetic compatibility (EMC) testing, and failure modes and effects analysis (FMEA)
Act as the point of escalation for technical and regulatory compliance matters, ensuring external and internal teams engage with safety certification bodies and comply with applicable standards
Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations
Risk Management & Problem-Solving:
Identify potential technical risks and implement mitigation strategies
Provide technical guidance in solving engineering challenges during the product development lifecycle
Person Specification:
Education
A degree or higher qualification in Biomedical / Electrical Engineering from a recognized university.
Masters in biomedical /electrical engineering will be an added advantage.
Experience
14+ years of overall experience in medical or electrical engineering, maintenance, and management with 10+ years in medical devices domain
5+ years of experience with a medical devices company in a leadership role
9+ years of experience in medical device development, circuit boards, and product design
Strong understanding of medical device regulations (ISO 13485, FDA 21 CFR Part 820, etc.)
Proven track record of leading teams in the design and development of Class II/III medical devices
Familiarity with product development lifecycle including concept, design, validation, and commercialization
Skills
Strong technical background in electrical engineering, electronics, and mechatronics, with experience in Medical Device development and/or sustaining engineering efforts
Proficient in circuit design, PCB layout, power management, analog and digital signal processing, and microcontroller-based systems
Expertise in managing R&D engineering projects, including performance tracking, SLA/KPI definition, contract negotiation, and demand planning
Proven ability to work through medical device product lifecycle management, including FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring alignment with strategic roadmaps
Experience in Project and Program Management, with a focus on vendor partner management, continuous improvement, and talent growth
Familiarity with Agile SCRUM environments and stage-gate processes, ensuring cross-functional collaboration to achieve business objectives
Capable of developing deliverables to document product designs for high-volume manufacturing and quality compliance
Technical expertise in printed circuit board design tools (Altium/Or CAD) and the ability to review schematics, component selection, and gerber data for PCB design and manufacturing
Experience planning and mitigating electromagnetic compatibility challenges in electrical projects
Strong knowledge of manufacturing methodologies for medical devices and the ability to solve complex technical problems with sound judgment
Proficiency in working with requirements management systems like DOORS, JAMA, and conducting risk analyses and DFMEAs
Excellent stakeholder management skills across PMO leads and vendor partner, ensuring timely project delivery and alignment with strategic goals
Experience managing large data sets, financial analysis, and P&L ownership, utilizing these insights to drive process improvements and operational efficiencies
Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partner, and leadership
Strong project management skills, with the ability to manage multiple projects simultaneously
Excellent communication, leadership, and problem-solving skills

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