Olympus Corporation
Website:
olympusamerica.com
Company:
https://www.linkedin.com/company/olympus-corp
Seniority: Mid-Senior level
Industries: Medical Equipment Manufacturing, Engineering Services, and Research Services
Job details:
About Olympus
We are an equal opportunities employer and we are committed to ensuring that no applicant or employee receives less favorable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements which cannot be shown.
The job is conducted in line with our Core Values which are: Patient Focus, Integrity, Innovation, Impact and Empathy. Olympus is an equal opportunities employer championing a culture of equality, diversity and inclusion embedded throughout the organization and workforce.
The Engineering Manager – Systems will lead a team of engineers responsible for the design, development, and delivery of medical device systems. The role focuses on project execution, technical leadership, and ensuring compliance with quality and regulatory standards, particularly in the medical device domain.
The ideal candidate will be a hands-on technical leader with extensive experience in developing and defining complex medical device systems involving electro-mechanical sub-systems which interact with embedded software. This role will be responsible for leading system engineering activities within the R&D function, with a strong focus on execution of engineering projects aligned to Olympus’ global R&D strategy. The Engineering Manager will drive R&D operations at the project level in India, leading system engineering teams and ensuring effective project delivery in close collaboration with global R&D and India leadership. The incumbent will manage project planning, resource allocation, and technical oversight, ensuring seamless coordination across cross-functional teams to meet timelines and deliverables.
From a technical perspective, the role will provide hands-on leadership to ensure high-quality engineering outcomes in the development of medical devices. This includes guiding design, analysis, prototyping, verification, and validation activities, while ensuring compliance with regulatory standards such as FDA Design Controls and ISO requirements. The position requires a strong balance of technical expertise and execution-focused leadership, fostering a collaborative environment and driving efficient delivery aligned with organizational goals
Key Responsibilities:
Functional Setup:
Lead and manage a team of system engineers, providing technical guidance and mentorship
• Drive end-to-end product development including design, prototyping, verification, and validation
• Ensure compliance with regulatory standards such as FDA, ISO 13485, and design controls
• Collaborate with cross-functional teams including R&D, quality, regulatory, and manufacturing
• Manage project timelines, resources, and deliverables aligned with business goals
• Review and approve design documentation including DHF, risk analysis, and test protocols
• Drive continuous improvement in engineering processes and tools
• Support vendor management and external partner collaboration
• Identify and mitigate technical risks throughout the product lifecycle
NPD, Sustaining & Stakeholder Management:
- Lead and drive execution of electrical engineering activities across New Product Development (NPD), Sustaining Engineering, and remediation programs.
- Provide hands-on technical guidance to ensure deliverables meet performance, regulatory, and quality requirements across product lifecycle stages
- Collaborate with PMO, Quality, Regulatory, Manufacturing, and global R&D teams to ensure alignment on project goals, timelines, and deliverables
- Support design control activities by guiding teams in DHF documentation, risk management (ISO 14971), and regulatory compliance (FDA, ISO, MDR, IEC, EU-MDR)
- Participate actively in CAPA investigations, root cause analysis, and implementation of corrective and preventive actions, ensuring timely closure and effectiveness
- Lead and support verification & validation (V&V) activities, including test strategy, protocol reviews, and ensuring robustness of test coverage
- Drive sustaining engineering efforts, including design changes, product improvements, cost optimization, and addressing field issues or customer feedback
- Ensure engineering solutions consider performance, reliability, manufacturability, cost, and safety, through structured design reviews and stakeholder collaboration
- Engage with global and cross-functional stakeholders to resolve technical challenges, mitigate risks, and ensure seamless execution of projects
Project Management & Execution:
- Act as the project-level interface between system engineering, PMO, and external partners, providing updates on progress, risks, and technical challenges
- Plan and manage engineering tasks, timelines, and resource allocation to ensure on-time and quality delivery across multiple programs
- Track and report project status, highlighting milestones, risks (RAID), and mitigation actions to key stakeholders
- Coordinate cross-functional activities, ensuring smooth integration of mechanical, electrical, and software components
- Ensure adherence to design control processes and quality systems, while driving continuous improvement in execution efficiency
- Provide hands-on leadership in prototyping, testing, and validation, ensuring compliance with product requirements and regulatory standards
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Regulatory & Compliance:
- Ensure that all product development activities meet regulatory and industry standards, including FDA, CE, ISO, IEC and other relevant certifications
- 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 Electrical/Mechanical/Software Engineering, Biomedical Engineering, or related fields from a recognized university.
A master's in electrical/mechanical/biomedical engineering will be an added advantage.
Experience
- 14+ years of overall experience in electrical engineering or medical device development with 10+ years in medical devices domain
- 3+ years of experience with a medical devices company in a leadership role
- 6+ years of experience in in system development, system integration, and product design involving software controlled electro-mechanical medical devices,
- Strong understanding of medical device regulations (IEC 60601, IEC 62304, 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
- Experience in medical imaging related systems design is an added advantage.
- Experience in leading medical device remediation teams is a an added advantage.
- Experience in leading multifunctional teams including embedded, electrical and mechanical engineers is a big plus.
Skills
- Strong technical background in systems engineering, with experience in Medical Device development and/or sustaining engineering efforts
- 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 simulation tools, ensuring cross-functional collaboration to achieve business objectives
- Familiarity in embedded design and/or medical Image processing is a big plus.
- Experience in electrical/systems/automation lab management and/or working with external labs like TuV etc., is a big plus.
- Proficiency in working with PLM (Product Lifecycle Management) systems and conducting risk analyses and DFMEAs
- Excellent stakeholder management skills across PMO leads and vendor partners, ensuring timely project delivery and alignment with strategic goals
- Effective communication skills, both verbal and written, with the ability to present information clearly to cross-functional teams, vendor partners, 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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