Medical Device Design Manager

📍 Job Overview

Job Title: Medical Device Design Manager Company: Renishaw Location: Charfield, United Kingdom Job Type: FULL_TIME Category: Engineering Operations / Product Development Date Posted: 2025-09-23T00:00:00 Experience Level: Mid-Senior Level (5-10 years) Remote Status: Hybrid (3 days/week onsite)

🚀 Role Summary

• Lead and manage the design and development of cutting-edge medical robotic devices, focusing on robotics design specialization.
• Oversee the entire product development lifecycle, from initial concept generation through to commercialization, ensuring seamless execution.
• Ensure strict adherence to medical device regulations, including FDA, ISO, and CE requirements, maintaining comprehensive documentation.
• Drive innovation and continuous improvement by integrating best practices and emerging technologies in robotics and medical device design.
• Foster a collaborative and high-performing multidisciplinary design team, promoting professional growth and technical excellence.

📝 Enhancement Note: While the title is "Design Manager", the responsibilities heavily lean into product development lifecycle management and regulatory compliance within a specialized engineering domain (robotics). This suggests a strong operational component in managing the design process and ensuring its outputs meet stringent GxP standards, making it relevant for operations-focused professionals who appreciate product development rigor. The hybrid nature with 3 days onsite points to a structured operational environment.

📈 Primary Responsibilities

• Team Leadership & Development: Lead, mentor, and develop a multidisciplinary team of design engineers, fostering a collaborative and innovative work environment to enhance technical and professional growth.
• Design & Development Oversight: Oversee the end-to-end design and development of medical robotic devices, ensuring compliance with industry standards (e.g., ISO 13485, IEC 60601) and regulatory requirements (FDA, CE).
• Project Lifecycle Management: Manage product development projects from concept to commercialization, collaborating with the project management office to define timelines, budgets, and resource allocation for successful project completion.
• Regulatory Affairs & Documentation: Ensure all designs meet relevant regulatory standards and prepare/maintain comprehensive documentation required for regulatory submissions and audits, demonstrating strong process control.
• Quality Assurance & Validation: Implement robust quality assurance processes and collaborate with QA teams for rigorous testing and validation of medical robotic devices to ensure safety, reliability, and performance.
• Cross-Functional Collaboration: Work closely with engineering, marketing, clinical affairs, and other stakeholders to align product design with market needs and user requirements, facilitating efficient Go-To-Market (GTM) strategies.
• Innovation & Process Improvement: Stay current with advancements in robotics and medical device design, identifying opportunities for innovation and integrating best practices and emerging technologies into the design process.

📝 Enhancement Note: The responsibilities highlight a deep integration of engineering design with operational management. Key duties include project management, regulatory compliance, and quality assurance, which are critical operational functions in the medical device industry. The emphasis on cross-functional collaboration and continuous improvement aligns with GTM operations principles.

🎓 Skills & Qualifications

Education:

• Bachelor's or Master’s degree in Mechanical Engineering, Biomedical Engineering, Robotics, or a closely related engineering discipline.

Experience:

• Approximately 8 years of progressive experience in medical device design and development.
• Proven track record of successfully leading design projects from initial concept through to market launch, demonstrating strong project execution capabilities.

Required Skills:

• Robotics Design Principles: Strong technical expertise in robotics design, including mechanical systems, actuation, sensing, and control systems.
• Medical Device Regulations: In-depth understanding of critical medical device regulations and standards such as FDA 21 CFR Part 820, ISO 13485, IEC 60601 series, and CE marking requirements.
• Leadership & Team Management: Demonstrated ability to lead, motivate, and manage engineering teams, fostering a culture of innovation and accountability.
• Project Management Methodologies: Proficiency in managing complex engineering projects, including scope definition, resource planning, risk management, and timeline adherence.
• CAD Software Proficiency: Expertise in utilizing advanced Computer-Aided Design (CAD) software for detailed design, simulation, and prototyping.
• Analytical Problem-Solving: Strong analytical and critical thinking skills to diagnose and resolve complex technical challenges in design and development.
• Communication Proficiency: Excellent verbal and written communication skills for effective technical information dissemination to diverse internal and external stakeholders.

Preferred Skills:

• Risk Management: Experience with formal risk management processes (e.g., ISO 14971) and Failure Mode and Effects Analysis (FMEA) within a medical device context.
• Systems Engineering: Familiarity with systems engineering principles for complex electromechanical products.
• User-Centric Design: Experience integrating user feedback and human factors engineering into the design process.
• New Product Introduction (NPI): Proven experience in managing the transition from design to manufacturing for new medical devices.

📝 Enhancement Note: The required skills blend technical engineering expertise with crucial operational management capabilities like project management, regulatory compliance, and team leadership. Proficiency in CAD and understanding of specific standards like ISO 13485 and IEC 60601 are vital for managing the operational aspects of product design in a regulated industry.

📊 Process & Systems Portfolio Requirements

Portfolio Essentials:

• Design Project Case Studies: Showcase a minimum of 2-3 comprehensive case studies detailing your leadership in medical device design projects, highlighting innovation, problem-solving, and successful outcomes.
• Process Optimization Examples: Include evidence of process improvements implemented within design or development workflows, demonstrating efficiency gains, cost reductions, or quality enhancements.
• Regulatory Compliance Documentation Samples: Provide anonymized examples of documentation created to meet regulatory requirements (e.g., design history file elements, risk analysis reports) to illustrate adherence to standards.
• Team Leadership & Project Management Artifacts: Present examples of project plans, team structures, or performance metrics managed, showcasing your ability to lead and organize design operations.

Process Documentation:

• Workflow Design and Optimization: Detail your approach to designing and optimizing engineering workflows, including stages from concept to release, ensuring robust process control and traceability.
• Implementation and Automation: Describe experience in implementing design-related processes and identifying opportunities for automation or digital tools to enhance efficiency and data integrity.
• Measurement and Performance Analysis: Outline how you measure the performance of design processes and teams, including key performance indicators (KPIs) related to cycle time, quality metrics, and budget adherence.

📝 Enhancement Note: For this role, a portfolio should emphasize not just the technical designs but the operational rigor behind them. This includes demonstrating how processes were managed, optimized, and documented to meet strict regulatory and quality standards. Evidence of successful NPI (New Product Introduction) processes and managing the design transfer to manufacturing would be highly valuable.

💵 Compensation & Benefits

Salary Range:

• Up to £70,000 per annum, dependent on experience and qualifications.

Benefits:

• Retirement: 9% non-contributory pension scheme.
• Performance: Discretionary annual bonus.
• Well-being: Subsidised onsite restaurants and coffee shops, 24-hour fitness centres, Health Cash Plan, Employee Assistance Programme (EAP) for employees and families.
• Commuting: Free parking, car sharing scheme, Cycle to Work scheme.
• Leave: 25 days of annual leave plus bank holidays.
• Financial Security: Life Assurance policy (12 times annual salary).
• Family Support: Enhanced maternity pay subject to qualifying criteria.
• Health Trust: Option to join BUPA Renishaw Health Trust.
• Additional Information: Access to a comprehensive benefits information page.

Working Hours:

• Typically 40 hours per week. The hybrid working policy allows for a combination of home and office-based working, with a requirement of 3 days per week onsite.

📝 Enhancement Note: The salary is competitive for a management role in the UK medical device sector, especially in specialized engineering fields. The benefits package is robust, indicating a strong focus on employee well-being and long-term commitment, which is attractive for operations professionals seeking stability and comprehensive support.

🎯 Team & Company Context

🏢 Company Culture

Industry: Medical Devices, Advanced Manufacturing, Engineering. Renishaw is a global leader in precision measurement, metrology, and spectroscopy, with a significant and growing presence in the medical sector, particularly in robotics for surgery and diagnostics. Company Size: Large – Renishaw is a multinational corporation with a significant global workforce, indicating a structured corporate environment with established processes and resources. Founded: 1973. With a history spanning over 40 years, Renishaw has a legacy of innovation and engineering excellence, which likely translates into a culture that values expertise, quality, and long-term vision.

Team Structure:

• Multidisciplinary Design Team: The manager will lead a team composed of various engineering disciplines (e.g., mechanical, electrical, software, controls) focused on robotics.
• Reporting Structure: Likely reports to a Director of Engineering or Head of Product Development, with direct reports in the design engineering function.
• Cross-functional Collaboration: Expect close collaboration with Product Management, Quality Assurance, Regulatory Affairs, Manufacturing Operations, Marketing, and Sales teams, requiring strong stakeholder engagement skills.

Methodology:

• Data-Driven Decision Making: Given Renishaw's focus on precision measurement, expect a strong emphasis on data analysis and metrics to drive design decisions and process improvements.
• Structured Product Development: The company's long history and industry position suggest a well-defined product development process, likely aligned with ISO 13485 and other relevant standards.
• Innovation & Continuous Improvement: A culture that encourages new ideas and the refinement of existing processes and products is probable, aligning with the "Innovation, Inspiration, Integrity, and Involvement" values.

Company Website: https://www.renishaw.com/

📝 Enhancement Note: Renishaw's established reputation in precision engineering and its expansion into medical robotics suggest a high-performance culture focused on quality, technical depth, and rigorous process adherence. Understanding these company values is crucial for aligning with the operational ethos.

📈 Career & Growth Analysis

Operations Career Level: This role represents a mid-to-senior management position within the product development operations, specifically focusing on the engineering design function for a critical product line. It involves managing both people and processes to deliver high-quality, compliant products. Reporting Structure: The Medical Device Design Manager will likely report to a higher-level engineering director or vice president, overseeing a team of engineers. This position requires strong collaboration with other operational leaders (QA, Manufacturing, Regulatory) to ensure seamless product realization. Operations Impact: The role has a direct impact on the company's ability to bring innovative and safe medical devices to market, influencing revenue generation through successful product launches and ensuring market competitiveness through efficient and high-quality design operations.

Growth Opportunities:

• Leadership Advancement: Potential to move into broader engineering management roles, such as Head of Product Development, VP of Engineering, or specialization in program management for larger initiatives.
• Technical Specialization: Opportunity to deepen expertise in robotics, surgical technologies, or other advanced medical device fields, potentially leading R&D for new technology platforms.
• Operational Excellence Roles: Progression into roles focused on optimizing the broader product development lifecycle, NPI processes, or quality systems management within the organization.
• Mentorship & Training: Opportunities to mentor junior engineers and contribute to the development of internal training programs for design and operations best practices.

📝 Enhancement Note: This role is a significant step for an operations-minded engineer, offering a blend of technical leadership and process management. The growth paths are clear within a large, established company like Renishaw, particularly in areas that bridge engineering execution with strategic business objectives.

🌐 Work Environment

Office Type: The role is based at the Charfield site, which is likely a modern, well-equipped facility supporting engineering and manufacturing operations. Given the hybrid nature, expect a professional office environment with dedicated workspaces for design and management activities. Office Location(s): Charfield, Gloucestershire, United Kingdom. This location offers a balance of operational facilities within a UK context.

Workspace Context:

• Collaborative Design Spaces: Expect access to modern CAD workstations, potentially 3D printing facilities, and meeting rooms equipped for technical reviews and cross-functional discussions.
• Technology Integration: The workspace will be equipped with the necessary software tools for design, simulation, project management, and communication, supporting efficient operations.
• Team Interaction: Opportunities for direct interaction with design teams, project managers, and stakeholders from other departments, fostering a dynamic and collaborative work environment.

Work Schedule:

• The standard working hours are approximately 40 hours per week.
• A hybrid working model is in place, requiring 3 days per week onsite, offering flexibility while maintaining team cohesion and operational oversight.

📝 Enhancement Note: The hybrid model with specific office days indicates a structured approach to work, balancing individual focus time with crucial team collaboration and face-to-face interactions essential for complex engineering and operational management.

📄 Application & Portfolio Review Process

Interview Process:

• Initial Screening: HR or Talent Acquisition review of application and CV, likely assessing alignment with core requirements and experience.
• Hiring Manager Interview: Focus on technical depth in robotics, medical device design experience, leadership style, and project management approach. Expect questions about past successes and challenges.
• Technical/Team Interview: Meeting with senior engineers or peers, assessing technical skills, problem-solving abilities, and cultural fit. This stage may involve technical discussions or a presentation.
• Portfolio Review: A dedicated session to present and discuss selected design project case studies, focusing on your role, process, challenges, and outcomes. Be prepared to articulate the operational aspects of your projects.
• Final Interview: Potentially with a senior leader (e.g., Director of Engineering) to discuss strategic fit, long-term vision, and overall suitability for the role and company culture.

Portfolio Review Tips:

• Focus on Operational Impact: For each case study, clearly articulate your role in managing the design process, any process improvements implemented, and how you ensured regulatory compliance and quality.
• Quantify Achievements: Use metrics to demonstrate the impact of your leadership and design efforts (e.g., reduced cycle time, improved product reliability, successful regulatory submissions, budget adherence).
• Structure Your Presentation: Organize your portfolio around key projects, using a clear narrative structure: problem, your approach (process/methodology), solution, results, and lessons learned.
• Highlight Collaboration: Showcase instances where you effectively collaborated with cross-functional teams to achieve design and operational goals.
• Demonstrate Regulatory Acumen: Be ready to discuss how you navigated regulatory requirements throughout the design process.

Challenge Preparation:

• Design Scenarios: Be prepared for hypothetical design challenges related to medical robotics, requiring you to outline a structured approach to problem-solving, considering technical feasibility, regulatory constraints, and user needs.
• Process Improvement Exercise: You might be asked to identify potential improvements in a given design process or workflow. Focus on efficiency, quality, and compliance.
• Leadership/Management Scenarios: Prepare for questions about how you manage team conflict, motivate engineers, handle underperformance, or prioritize competing projects.

📝 Enhancement Note: The interview process emphasizes not only technical design skills but also the ability to manage processes, teams, and regulatory requirements effectively. A strong portfolio that showcases operational rigor in design is critical for success.

🛠 Tools & Technology Stack

Primary Tools:

• CAD Software: Proficiency in industry-standard CAD software such as SolidWorks, CATIA, or similar, for detailed mechanical design, assembly, and drafting.
• Simulation & Analysis Tools: Experience with FEA (Finite Element Analysis) and CFD (Computational Fluid Dynamics) software for design validation and performance prediction.
• PLM/PDM Systems: Familiarity with Product Lifecycle Management (PLM) or Product Data Management (PDM) systems for managing design data, revisions, and workflows.
• Project Management Software: Tools like Microsoft Project, Jira, Asana, or similar for planning, tracking, and managing project timelines and resources.

Analytics & Reporting:

• Data Analysis Tools: Ability to use data analysis tools (e.g., Excel, Python libraries like Pandas, MATLAB) to interpret test results, performance metrics, and user feedback.
• Reporting Tools: Experience with generating reports and dashboards to communicate project status, design performance, and key operational metrics to stakeholders.

CRM & Automation:

• CRM Systems: While not directly customer-facing, understanding how product designs integrate with CRM data (e.g., customer feedback on products) can be beneficial.
• Automation Tools: Familiarity with automation in design processes, such as generative design tools, automated testing frameworks, or workflow automation within PLM systems.

📝 Enhancement Note: This role requires a manager who is comfortable with the tools that underpin efficient engineering operations. Expertise in CAD, simulation, PLM, and project management software is essential for overseeing design execution and process adherence.

👥 Team Culture & Values

Operations Values:

• Innovation: Encouraging creative solutions and embracing new technologies to push the boundaries of medical robotics.
• Inspiration: Motivating the team to achieve ambitious goals and contribute to meaningful advancements in healthcare.
• Integrity: Upholding the highest ethical standards in design, development, and regulatory compliance, ensuring patient safety and product reliability.
• Involvement: Fostering a sense of shared purpose and encouraging active participation from all team members in problem-solving and decision-making processes.

Collaboration Style:

• Cross-functional Integration: Emphasizing seamless collaboration between design engineering and other operational departments (QA, Manufacturing, Regulatory, Marketing) to ensure a holistic approach to product development.
• Process-Oriented Feedback: Encouraging a culture where feedback on processes and designs is openly shared and acted upon to drive continuous improvement.
• Knowledge Sharing: Promoting an environment where engineers share technical knowledge, best practices, and lessons learned to elevate the team's collective expertise and operational efficiency.

📝 Enhancement Note: Renishaw's stated values of Innovation, Inspiration, Integrity, and Involvement provide a strong framework for understanding the expected work culture. For an operations manager, this translates to leading with ethical rigor, fostering creativity, driving team engagement, and ensuring collaborative processes.

⚡ Challenges & Growth Opportunities

Challenges:

• Navigating Complex Regulations: Staying ahead of evolving medical device regulations and ensuring consistent compliance across all design iterations and projects.
• Balancing Innovation with Rigor: Fostering a creative environment while maintaining the strict process controls and documentation required for medical devices.
• Managing Cross-Functional Dependencies: Effectively coordinating with diverse departments, each with its own priorities and operational constraints.
• Rapid Technological Advancements: Keeping pace with the fast-evolving field of robotics and integrating new technologies efficiently into product development cycles.

Learning & Development Opportunities:

• Advanced Robotics & AI: Access to training and resources on the latest advancements in robotics, machine learning, and AI relevant to medical applications.
• Medical Device Industry Trends: Opportunities to attend industry conferences, webinars, and gain insights into market dynamics and emerging healthcare technologies.
• Leadership & Management Training: Internal and external programs focused on enhancing leadership, strategic planning, and operational management skills.
• Process Excellence Certifications: Potential support for obtaining certifications in areas like Lean, Six Sigma, or Agile methodologies relevant to product development operations.

📝 Enhancement Note: The challenges presented are typical for leadership roles in the medical device sector. The growth opportunities are well-aligned with career progression in operations, offering pathways to deepen technical knowledge or expand into broader management and strategic roles.

💡 Interview Preparation

Strategy Questions:

• Design Process & Methodology: "Describe your approach to managing the design lifecycle of a complex medical robotic device, from concept to verification and validation. How do you ensure process adherence and quality?" (Focus on structured processes, risk management, and documentation).
• Team Leadership & Development: "How do you motivate and develop a team of highly skilled engineers? Provide an example of how you've fostered innovation or improved team performance." (Highlight leadership style, feedback mechanisms, and growth support).
• Problem-Solving & Decision Making: "Describe a time you faced a significant technical challenge during a medical device design project. How did you analyze the problem, what process did you follow, and what was the outcome?" (Emphasize analytical skills, systematic approach, and outcome-driven solutions).

Company & Culture Questions:

• Alignment with Values: "How do Renishaw's values of Innovation, Inspiration, Integrity, and Involvement resonate with your leadership philosophy and approach to managing engineering operations?" (Connect your past experiences and principles to the company's stated values).
• Cross-functional Collaboration: "How do you ensure effective collaboration and communication between the design team and other critical departments like Quality Assurance, Manufacturing, and Regulatory Affairs?" (Provide examples of successful cross-functional initiatives).
• Impact Measurement: "How do you measure the success of your design team and the products they deliver? What key performance indicators (KPIs) do you track?" (Focus on metrics related to project delivery, product performance, and operational efficiency).

Portfolio Presentation Strategy:

• Operational Narrative: For each project, weave a narrative that highlights not only the technical design but also the operational management: project planning, resource allocation, risk mitigation, regulatory compliance steps, and process improvements.
• Data-Driven Evidence: Use charts, graphs, and specific metrics to demonstrate the impact of your leadership and the success of your projects. Quantify improvements in cycle time, quality, cost, or compliance.
• Concise and Focused: Be selective about the projects you present, choosing those that best showcase your leadership, operational management skills, and understanding of the medical device landscape.
• Anticipate Questions: Be prepared to answer detailed questions about your specific contributions, the challenges encountered, and the rationale behind your decisions.

📝 Enhancement Note: Interview preparation should focus on demonstrating a strong understanding of both engineering principles and operational best practices, particularly within the highly regulated medical device industry. Highlighting experience with process management, regulatory compliance, and team leadership will be key.

📌 Application Steps

To apply for this Medical Device Design Manager position:

• Submit your application through the provided link on the Renishaw careers portal.
• Operations Portfolio Customization: Curate your professional portfolio to prominently feature 2-3 detailed case studies of medical device design projects you have managed. For each, emphasize your leadership role, the design process followed, how you ensured regulatory compliance (mentioning specific standards like ISO 13485, IEC 60601), any process improvements implemented, and the quantifiable outcomes.
• Resume Optimization: Tailor your resume to highlight keywords relevant to medical device design, robotics, engineering management, project management, regulatory affairs (FDA, ISO, CE), quality assurance, and process optimization. Clearly articulate achievements using action verbs and quantifiable results.
• Interview Preparation: Practice articulating your experience using the STAR method (Situation, Task, Action, Result) for common behavioral and technical questions. Prepare a concise presentation of your portfolio, focusing on the operational aspects of your project management and design leadership. Research Renishaw's products, market position, and company values.
• Company Research: Gain a thorough understanding of Renishaw's business, particularly their medical device division and robotics initiatives. Familiarize yourself with their company culture and values to better align your responses during the interview process and demonstrate your suitability for their operational environment.

⚠️ Important Notice: This enhanced job description includes AI-generated insights and operations industry-standard assumptions. All details should be verified directly with the hiring organization before making application decisions.