Principal/ Senior Manufacturing Process Engineer (Lifecycle Management)

Job description

Bring more to life. Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology? At Leica Microsystems, one of Danaher’s 15+ operating companies, our work saves lives—and we’re all united by a shared commitment to innovate for tangible impact. You’ll thrive in a culture of belonging where you and your unique viewpoint matter. And by harnessing Danaher’s system of continuous improvement, you help turn ideas into impact – innovating at the speed of life. Shape the Future with Us! At Leica Microsystems, we have been shaping the future for over 175 years with groundbreaking optical and digital solutions. With a culture rooted in customer focus, innovation, and teamwork, we lead the market in microscopy, imaging, and analysis, unveiling the invisible and empowering our customers to build a better, healthier world. Joining Leica Microsystems means contributing to scientific discoveries and supporting surgeons in making critical decisions. Our advanced microscopes and AI-based image analysis solutions enable users to gain profound insights into development and engineering challenges. Here, you will work on meaningful projects alongside passionate colleagues, driving progress and pushing the boundaries of what’s possible. Learn about the Danaher Business System which makes everything possible. The Principal/ Senior Manufacturing Process Engineer is responsible for establishing, sustaining, and optimizing medical device assembly processes to improve safety, quality, delivery, productivity, cost, and regulatory compliance. The role provides manufacturing engineering support across process validation, production issue resolution, engineering changes, controlled documentation, training, and continuous improvement. This position reports to the Director, Project & Engineering and is part of the Process Engineering team located in Singapore and will be an on-site role. In this role, you will have the opportunity to: Improve medical device manufacturing performance by monitoring First Pass Yield, process capability, productivity, Material Review Board trends, and recurring production issues, then implementing sustainable corrective and preventive actions. Provide day-to-day process and product engineering support following new product design transfer, including troubleshooting, containment, root-cause analysis, complaint investigation, and resolution of manufacturing and product issues. Plan, execute, document, and maintain qualification and validation of manufacturing processes, tools, fixtures, and equipment, including preventive maintenance requirements and process requalification. Coordinate engineering changes and maintain production readiness across controlled documents, materials, tooling, training, SAP data, process risk assessments, control plans, routings, and work instructions. Develop and sustain standard work and manufacturing playbooks using Lean and Danaher Business System tools, while supporting supplier qualification, first article testing, audits, inspection readiness, and compliance improvement activities. The essential requirements of the job include: Bachelor's degree in Mechatronics, Electrical, Electronics, Industrial, Production, Mechanical Engineering, or a related engineering discipline. Minimum 5 years of related experience in a Lean manufacturing or production environment, including at least 3 years in medical device manufacturing. Knowledge of medical device quality and regulatory requirements, including ISO 13485 and Medical Device Single Audit Program requirements. Experience with manufacturing process validation, jig and fixture design, Failure Mode and Effects Analysis, Design of Experiments, and structured root-cause problem solving. Working knowledge of SAP and controlled manufacturing documentation, such as process risk assessments, control plans, routings, inspection instructions, and production work instructions. It would be a plus if you also possess previous experience in: Supporting audits, inspection readiness, remediation activities, and Device History Record accuracy in a regulated manufacturing environment. Leading complaint, warranty, corrective and preventive action, or supplier quality investigations through failure analysis and corrective-action implementation. Delivering production training and deploying Lean or Danaher Business System standard work across assembly operations. Leica Microsystems, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it is a health care program or paid time off, our programs contribute to life beyond the job. Check out our benefits at Danaher Benefits Info. #LI-onsite #LI-VH1 Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life. For more information, visit www.danaher.com.