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:

1. Lead the functional setup and management of the electrical function, optimizing workflows, task assignment, hiring/team set-up and resource management
2. Seek to ideate enhancements to systems and processes with the goal of increasing product development efficiency, communication, and/or quality
3. 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
4. Develop and oversee technical training and knowledge-sharing programs for internal teams, fostering continuous skill development and alignment with Olympus technical standards
5. 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
6. Implement continuous improvement initiatives within the electrical engineering function, driving technical process enhancements and increasing the efficiency and quality of product development across teams
7. Identify and implement cutting-edge technologies and engineering practices to improve product performance and drive innovation
8. Participate in strategic planning and provide technical insights to support long-term growth and competitiveness
9. Recruit staff, develop them through assignments, guidance, and mentorship, and manage their performance
10. Create systems to ensure all updates/changes are communicated across sites/employees

NPD and Stakeholder Management:

1. 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
2. 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
3. Oversee the design and development of electrical systems, including circuit design, PCB layout, power management, and signal processing for medical devices
4. Ensure designs are optimized for safety, reliability, manufacturability, and compliance with medical device standards
5. Manage the selection and integration of components, sensors, and electronic systems that meet design requirements and regulatory standards
6. Collaborate with Olympus PMO teams to develop and monitor technical roadmaps, ensuring smooth execution of project goals and resource allocations
7. Act as the subject matter expert on design control for electrical R&D, provide guidance to product development teams (both internal and external)
8. Ensure that design solutions meet performance, cost, manufacturability, and safety requirements through effective review and communication with global stakeholders
9. 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
10. Facilitate technical problem-solving by coordinating with global leads, ensuring swift resolution of challenges and minimizing project delays

Project Management:

1. 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
2. Develop and manage technical roadmaps with input from vendor partner, ensuring timelines, milestones, and resource planning are optimized for the electrical R&D function
3. Regularly report project status to PMO leads and Olympus global teams, ensuring visibility of key technical achievements and roadblocks, and adjusting strategies as needed
4. Manage and oversee the maintenance of technical RAID logs, working with vendor partner to ensure risks are identified, escalated, and addressed promptly
5. Oversee coordination between vendor partner and software development teams to ensure seamless integration of electrical designs into broader product architectures
6. Ensure adherence to Olympus design control procedures and drive continuous improvements in these processes to enhance clarity, compliance, and usability
7. Provide high-level guidance on the verification and validation testing strategies proposed, ensuring they meet Olympus quality and performance specifications

Regulatory & Compliance:

1. Ensure that electrical designs meet relevant regulatory standards (IEC 60601, ISO 13485, FDA 21 CFR Part 820) and safety standards (UL, CE)
2. Lead risk management activities, including electrical safety analysis, electromagnetic compatibility (EMC) testing, and failure modes and effects analysis (FMEA)
3. 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
4. Maintain documentation in compliance with Good Manufacturing Practices (GMP) and quality system regulations

Risk Management & Problem-Solving:

1. Identify potential technical risks and implement mitigation strategies
2. 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/OrCAD) 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