Senior Automation Engineer - Lead

Role Summary

Senior Automation Engineer - Lead. Lead a team of automation engineers to develop and scale automation solutions for high-volume medical device and life sciences manufacturing. Focus on core technology development, manufacturing scale-up, and operational excellence in a highly regulated environment. Hands-on leadership with collaboration across Engineering, Manufacturing, Biology, Quality, Facilities, and Sustaining.

Responsibilities

• 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.
• 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 current manufacturing processes and workflows, identify opportunities for improved performance/throughput by applying knowledge of product design, fabrication, assembly, tooling, and materials, and solicit operator feedback.
• Lead root cause investigations for automation-related issues and implement corrective and preventive actions to drive continuous improvement.
• 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 design, create URS, conduct concept reviews, provide proof of concept through prototyping/testing data, coordinate with stakeholders for 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.
• 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 URS, conduct concept reviews, provide proof of concept through prototyping/testing data, coordinate with stakeholders for verification/validation, launch, and documentation.

Qualifications

• 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.

Education

• Bachelor's Degree in Mechanical, Electrical, Biomedical Engineering or equivalent.

Preferred Qualifications

• Master‚Äôs 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.