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

Purpose of the Role:

The Staff Mechanical Engineer will focus on the technical execution of mechanical engineering projects within Olympus. Reporting to the Associate Director, this role emphasizes technical leadership while maintaining some project management responsibilities. The individual will collaborate closely with global R&D and India leads to drive the design, development, and troubleshooting of mechanical systems for medical devices.

This position will take charge of strategic technical oversight, particularly in vendor partner management, ensuring high-quality engineering outcomes and adherence to regulatory standards such as FDA Design Controls. While contributing to project planning and delivery, the focus will be on leading technical initiatives, ensuring alignment with the broader R&D strategy and offshore operational goals. The role requires proactive liaison with internal teams and external partners to maintain seamless coordination and ensure the timely achievement of project milestones.

Key Responsibilities:

NPD and Stakeholder Management:

Lead hands-on development and execution of mechanical designs, driving the implementation of complex mechanical systems from concept through to production, with a focus on achieving performance, reliability, and regulatory compliance in every phase
Demonstrated fluency in modeling of components for machined parts, molded parts using tools such as Solid works, Pro-E, Cryo
Extensive demonstrated knowledge in tolerance and stack up analysis for materials (metal and plastic) parts
Demonstrated experience in DFM (Design for manufacturing)
Perform detailed design reviews with internal teams and vendor partners, offering technical expertise to refine mechanical architectures and ensuring they meet all Olympus R&D objectives
Implement advanced mechanical engineering techniques, such as structure finite element analysis (FEA), thermal analysis, materials selection, and design for manufacturability (DFM) to drive high performance and reliability
Collaborate with cross-functional teams (systems, software, electrical engineers) to ensure seamless integration of mechanical designs into overall product architecture and meet system-level requirements
Provide technical mentorship to junior engineers and vendor partners, ensuring that best practices are followed and that technical decisions are aligned with Olympus long-term innovation strategies
Ensure seamless communication of technical updates between stakeholders, including Olympus global teams, regulatory bodies, and vendor partners, focusing on detailed design compliance and technical specifications
Develop and validate test protocols for mechanical systems, ensuring designs are robust, reliable, and scalable while adhering to safety and regulatory standards

Project Management:

Lead technical tracking of project progress, developing detailed Gantt charts and project plans that map out technical milestones, dependencies, and resource needs for mechanical R&D activities
Coordinate with the PMO teams to ensure technical objectives are aligned with project timelines, adjusting designs and technical approaches to mitigate risks or delays
Create and manage technical resource plans, ensuring that internal engineering teams and vendor partners have the tools, talent, and resources required to meet demanding project timelines
Proactively troubleshoot and resolve technical challenges, leveraging advanced engineering methodologies like root cause analysis (RCA), failure mode effect analysis (FMEA), and reliability testing to resolve bottlenecks
Support RAID management by identifying and documenting key technical risks, ensuring that each risk has an associated mitigation plan grounded in strong engineering fundamentals
Provide in-depth technical reports to the PMO on project progress, focusing on design validation, testing outcomes, technical issues encountered, and proposed engineering solutions
Oversee technical escalations, ensuring that all technical roadblocks are swiftly identified and addressed, with proposed solutions backed by solid technical rationale

Practice Development:

Lead technical setup of engineering tools and workflows, including implementing software for mechanical design, lab setups, and testing protocols for streamlined development within the function
Develop and oversee technical processes, including change control, design reviews, and prototype testing, ensuring the function operates with cutting-edge engineering efficiency
Establish advanced testing and validation protocols, ensuring that all mechanical systems developed in the function meet high standards for performance, durability, and compliance
Direct hands-on prototyping and debugging, focusing on early-stage system validation, material selection, and mechanical design tuning to meet evolving project needs
Drive continuous improvement initiatives to optimize technical workflows, reduce design cycles, and improve overall engineering output quality by integrating feedback from testing and real-world results
Ensure all mechanical designs meet global regulatory and safety standards, working closely with regulatory bodies and certification teams to ensure the function's output aligns with industry regulations
Manage technical knowledge-sharing sessions within the function, facilitating the exchange of engineering know-how between internal teams and external vendor partners to elevate the overall technical skill set

Regulatory & Compliance:

Support the Associate Director in ensuring product development aligns with regulatory and industry standards, including FDA, CE, ISO, and other relevant certifications
Assist in engaging with external teams and certification bodies to ensure compliance with applicable safety standards
Help maintain documentation in accordance with Good Manufacturing Practices (GMP) and quality system regulations

Risk Management & Problem-Solving:

Work with the team to identify technical risks and support the development of mitigation strategies
Provide input and technical support to address engineering challenges throughout the product development process

Person Specification:

Education

A degree or higher qualification in Biomedical / Mechanical Engineering from a recognized university.

Masters in biomedical /Mechanical engineering will be an added advantage.

Experience

10+ years of experience in Mechanical Engineering R&D in the medical devices domain, with a mix of technical and managerial responsibilities
Proven experience in collaborating with PMOs and global teams on mechanical projects
Strong technical background in mechanical design, circuit board development, and compliance with regulatory standards
Experience in medical device development is preferred

Skills

Strong technical expertise in mechanical engineering, materials science, and product design, with hands-on experience in R&D and/or sustaining engineering, especially in product development environments
Experience working with vendor partners on R&D projects, assisting in performance tracking, SLA monitoring, and supporting demand planning to ensure alignment with project requirements
Familiarity with medical device product lifecycle management, with experience in applying FDA Design Controls and international standards (e.g., 820-CFR, ISO14971, IEC60601), ensuring compliance with project-specific regulations
Experience in supporting project and program management efforts, with a focus on managing day-to-day vendor partner interactions, driving continuous improvement in engineering processes, and contributing to team growth
Comfortable working in Agile SCRUM and stage-gate environments, ensuring collaboration with cross-functional teams to meet project objectives
Ability to develop and contribute to design documentation, including CAD models, specifications, and compliance records for manufacturability and quality assurance
Knowledge of materials compatibility, durability testing, and mechanical design principles, contributing to design solutions to mitigate risks
Understanding of manufacturing processes for mechanical components, including injection molding, machining, and rapid prototyping, and experience with managing design for manufacturability
Experience with requirements management systems (e.g., DOORS, JAMA), contributing to risk analysis and DFMEA processes in mechanical R&D projects
Effective stakeholder management skills, collaborating with PMO teams to ensure technical alignment and timely project delivery
Experience working with project data, contributing to technical assessments and identifying opportunities for process improvements and operational efficiency
Strong communication skills, with the ability to present technical updates and information clearly to cross-functional teams and stakeholders

Staff Mechanical Engineer (R&D)