Senior Automation Engineer - Lead

Rani Therapeutics Inc.; England; On-site; GBP 60,000 - 90,000; Full time

Job summary

A leading medical device company in the UK is seeking an experienced Automation Manager/Lead to oversee automation solutions for medical device manufacturing. The role involves strategic leadership in driving technology development and ensuring compliance with regulatory standards. The ideal candidate will possess significant experience in automation technology and team management. This hands-on position requires collaboration with various departments to achieve operational excellence.

Qualifications

• 5-10 years of hands-on leadership experience.
• Experience with FDA regulations and quality management standards.
• Strong understanding of mechanical/electromechanical design.

Responsibilities

• Direct a team of automation engineers to develop solutions.
• Oversee automation strategies for manufacturing excellence.
• Ensure compliance with FDA regulations and quality standards.

Skills

Leadership

Technical expertise

Problem-solving

Analytical skills

Communication

Education

Bachelor's Degree in Mechanical, Electrical, or Biomedical Engineering

Tools

SolidWorks

PLC programming

Job description

We are seeking an experienced Automation Manager/Lead to direct a team of automation engineers in developing and scaling cutting‑edge automation solutions for high‑volume medical device and life sciences manufacturing. This strategic leadership role focuses on deep automation core technology development, manufacturing scale‑up, and driving operational excellence through advanced automated systems. The ideal candidate will combine strong technical expertise with exceptional leadership capabilities to build automation platforms that ensure regulatory compliance, precision, and efficiency in a highly regulated environment. This is a hands‑on position that requires interaction and collaboration with a cross‑functional team including Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

Major Duties and Responsibilities

Strategic Leadership & Technology Development

• Lead the development and execution of the site automation master plan and roadmap aligned with organizational goals and industry standards.
• Drive innovation in automation core technologies including DCS, PLC, SCADA systems, robotics integration, and Industry 4.0 platforms to support high‑volume production.
• Establish automation strategies that enable continuous manufacturing, process optimization, and scalability for medical device production.
• Oversee the architecture, design, and implementation of automated systems from concept through validation, ensuring solutions meet both current and future manufacturing demands.
• Lead, mentor, and develop a high‑performing team of automation engineers by fostering collaboration, continuous learning, and technical excellence.
• Provide coaching, identify skill gaps, and offer professional development to promote growth and strengthen competencies.
• Empower team members by setting clear roles, goals, and expectations using frameworks like OKRs and SMART goals, while ensuring accountability and alignment.
• Coordinate closely with cross‑functional teams, external partners, and key stakeholders to achieve project objectives on time and within budget.
• Facilitate regular meetings, establish effective communication channels, and maintain good design control practices through detailed project planning.
• Serve as the technical liaison, promoting transparency and translating technical requirements into business outcomes.
• Establish and manage strategic relationships with automation vendors, equipment suppliers, contract manufacturers, and technology partners.
• Lead vendor selection, procurement, and onboarding processes for capital equipment including robotics, vision systems, PLCs, and automated assembly systems.
• Oversee vendor performance monitoring, contract compliance, and service‑level agreements to ensure quality deliverables and cost‑effectiveness.
• Coordinate with vendors on system integration, qualification activities, and lifecycle management to maintain supportability and mitigate obsolescence risks.

Scale‑Up & Manufacturing Excellence

• Drive automation initiatives to scale production from pilot to high‑volume manufacturing while maintaining quality, compliance, and throughput targets.
• Develop digital twins, takt‑time modeling, and throughput optimization strategies to maximize line efficiency and minimize downtime.
• Evaluate the current manufacturing processes & workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials as well as soliciting feedback from operators.
• Lead root cause investigations for automation‑related issues and implement corrective and preventive actions to drive continuous improvement.

Regulatory Compliance & Quality Systems

• Ensure all automation solutions comply with FDA regulations, ISO 13485, cGMP, 21 CFR Part 11, and other applicable quality management standards.
• Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation.
• Oversee creation and execution of FAT, SAT, and validation protocols (IQ/OQ/PQ), design controls, and documentation in accordance with regulatory requirements.
• Implement automated compliance monitoring, traceability systems, and electronic batch records to enhance audit readiness and reduce compliance risk.
• Maintain lifecycle management of automation systems ensuring all platforms remain on supported, validated configurations.

Project & Resource Management

• Develop detailed project plans with clear timelines, milestones, resource requirements, and deliverables using structured project management methodologies.
• Manage CAPEX and OPEX budgets for automation initiatives, ensuring cost‑effective solutions and strong return on investment.
• Balance multiple priorities across concurrent projects, effectively allocating resources and managing dependencies.
• Track and report on key performance metrics including first‑pass yield, uptime, cycle time, and automation ROI.
• Take full ownership of the design, create User Requirements Specification (URS), conduct concept reviews, show proof of concept through prototyping/supporting test data, coordinate with appropriate stakeholders for successful verification/validation, launch, and documentation.

Education and/or Job Experience

• Bachelor's Degree in Mechanical, Electrical, Biomedical Engineering or equivalent.
• 5 - 10 years hands‑on leadership relevant experience.
• In‑depth experience with complex mechanical/electromechanical design.
• Extensive experience with precision mechanisms, pneumatics, servo systems, tooling/fixtures, and mechanical components such as motors, belts/pulleys, gears, actuators, sensors, etc.
• Experience with creating engineering drawings, BOMs and product specifications.
• Deep knowledge of material properties, heat treatment, and surface finish.
• Proven track record with Medical Device Manufacturing Methods/Procedures, FDA regulations, ISO, cGMP, and QMS standards.
• Good understanding of DFM and lean manufacturing.
• Excellent verbal, written, presentation and interpersonal skills.
• Strong analytical and problem‑solving skills.
• Knowledge and/or hands‑on experience with machine shop tools.
• Deep knowledge of GD&T as well as proficiency with SolidWorks.
• Creative, self‑motivated and flexible to work in a small company environment and assume a wide variety of tasks.

Preferred Qualifications

• Master’s degree in Mechanical Engineering or equivalent.
• Knowledge/experience with plastic injection molding.
• Knowledge/experience with DOE, SPC, JMP /Minitab.
• Experience with metal stamping, laser cutting and chemical etching.
• Familiarity with and sterilization process and aseptic environment.
• PLC programming, SCADA, Ladder Logic preferred.