Principal/ Senior Manufacturing Process Engineer (Lifecycle Management)

Posted 2 Hours Ago
Be an Early Applicant
Singapore, SGP
In-Office
Senior level
Healthtech
The Role
Leads the establishment, validation, optimization, and ongoing support of medical device assembly processes. Responsibilities include troubleshooting production issues, root-cause analysis, engineering changes, controlled documentation, process and equipment qualification, continuous improvement, supplier support, audits, training, and regulatory compliance.
Summary Generated by Built In

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.

Skills Required

  • Bachelor’s degree in Mechatronics, Electrical, Electronics, Industrial, Production, Mechanical Engineering, or a related engineering discipline.
  • At least 5 years of related experience in a Lean manufacturing or production environment.
  • At least 3 years of experience in medical device manufacturing.
  • Knowledge of medical device quality and regulatory requirements, including ISO 13485 and MDSAP.
  • Experience with manufacturing process validation.
  • Experience with jig and fixture design.
  • Experience with Failure Mode and Effects Analysis.
  • Experience with Design of Experiments.
  • Experience with structured root-cause problem solving.
  • Working knowledge of SAP and controlled manufacturing documentation.
  • Experience supporting audits, inspection readiness, remediation activities, and Device History Record accuracy.
  • Experience leading complaint, warranty, corrective and preventive action, or supplier quality investigations.
  • Experience delivering production training and deploying Lean or Danaher Business System standard work.

Danaher Corporation Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Danaher Corporation and has not been reviewed or approved by Danaher Corporation.

  • Healthcare Strength — Healthcare coverage is described as comprehensive, including medical plan options alongside dental, vision, life, disability, and mental health support. Wellness initiatives and support programs such as an EAP and vaccination or fitness offerings add breadth beyond core insurance.
  • Retirement Support — Retirement benefits include a 401(k) plan with employer matching and options such as pre-tax and Roth contributions. Broader financial rewards such as performance bonuses and access to equity or an employee stock purchase plan are also described.
  • Parental & Family Support — Parental leave and family-building support are described as available, including maternity and paternity leave and fertility assistance. Childcare and eldercare support are also highlighted as part of the overall package.

Danaher Corporation Insights

Am I A Good Fit?
beta
Get Personalized Job Insights.
Our AI-powered fit analysis compares your resume with a job listing so you know if your skills & experience align.

The Company
HQ: Washington, DC
57,802 Employees
Year Founded: 1984

What We Do

Danaher is a global science and technology innovator committed to helping our customers solve complex challenges and improve quality of life around the world. A global network of more than 25 operating companies, we drive meaningful innovation in some of today’s most dynamic industries through our operating companies in four strategic platforms: Life Sciences, Diagnostics, Water Quality and Product Identification. The engine at the heart of our success is the Danaher Business System (DBS), a set of tools that enables continuous improvement around lean, growth and leadership. Through the ingenuity of our people, the power of DBS and the impact of our meaningful technologies, we help realize life’s potential in ourselves and for those we serve.

Similar Jobs

Hybrid
Singapore, SGP
289097 Employees

Citadel Logo Citadel

Software Engineer

Information Technology • Software • Financial Services • Big Data Analytics
In-Office
5 Locations
4000 Employees
150K-300K Annually

Airwallex Logo Airwallex

Senior Software Engineer

Artificial Intelligence • Fintech • Payments • Business Intelligence • Financial Services • Generative AI
In-Office
2 Locations
2700 Employees

Sonar Logo Sonar

Research Engineer

Artificial Intelligence • Cloud • Security • Software
Easy Apply
Hybrid
Singapore, SGP
800 Employees

Similar Companies Hiring

Granted Thumbnail
Artificial Intelligence • Healthtech • Insurance • Mobile • Financial Services
New York, New York
23 Employees
OneImaging Thumbnail
Healthtech
Miami, FL
62 Employees
Vitalize Thumbnail
Artificial Intelligence • Healthtech • Software
US
50 Employees

Sign up now Access later

Create Free Account

Please log in or sign up to report this job.

Create Free Account