Test Manufacturing Lead Engineer (Medical)

Req ID: 127549

Remote Position: No

Region: Asia

Country: Malaysia

State/Province: Johor

City: Senai

Summary

The Senior Test Engineer, Test Manufacturing accepts, transfers, performance installation and qualification according to medical devices standard requirements, improves and maintains automatic test equipment and test programs that are used for product testing and design verification. They also may support the test development of the test equipment and processes to ensure robust and high quality test solutions and final products are realized.

Detailed Description

Performs tasks such as, but not limited to, the following:

• Develop and implement detailed test plans and procedures for medical devices, covering functional, performance, and regulatory requirements.
• Prepare comprehensive test IQOQPQ protocol and reports, document test results, and maintain records for audits.
• Contribute to risk assessments and mitigation strategies for medical devices.
• May interact with customers to understand requirements and address complex issues.
• Provide technical direction on test strategies and methodologies, and contribute to process improvements.
• Unassisted, define, specify, qualify, install, support and optimize test process and test equipment solutions for manufacturing.
• Lead test process optimization, with a focus on productivity improvements to cycle time and yield for a broad set of test equipment within an Operations value stream.
• Debug of test process and equipment solutions using design of experiments, tools, and failure analysis methodologies.
• Collaborate with Quality, Process and Equipment engineers to detect and solve product and test yield and performance issues
• Develop improvement roadmaps for test coverage, diagnosability, reparability, test time reductions and OEE
• Analyzing and interpreting data and information from yield reports and equipment logs and product diagnostics to determine sources of yield loss
• Provide solution support to Process Engineers to improve detection of known defect types as part of a Process Control plan
• Support development of test equipment integration into Manufacturing Execution Systems including yield, tester log and product parametric information.
  
  

Knowledge/Skills/Competencies

• Bachelor's degree in Engineering (Electrical, Biomedical, or related field).
• Extensive experience in testing medical devices and related standards.
• Strong understanding of regulatory requirements for medical devices.
• Proficiency in test automation tools and methodologies.
• Excellent problem-solving, analytical, and communication skills.
• Experience with risk management processes for medical devices.
• Leadership and mentorship experience.
• Familiarity with software development life cycle processes for medical devices
  
  

Physical Demands

• Duties of this position are performed in a normal office environment.
• Duties may require extended periods of sitting and sustained visual concentration on a computer monitor or on numbers and other detailed data.
• Repetitive manual movements (e.g., data entry, using a computer mouse, using a calculator, etc.) are frequently required.
• Occasional travel may be required.
  
  

Typical Experience

• 3 to 5 years experience with medical devices product.
• More than 5 years experience in test department.
  
  

Typical Education

Bachelor degree or consideration of an equivalent combination of education and experience.

Educational Requirements may vary by Geography

Notes

This job description is not intended to be an exhaustive list of all duties and responsibilities of the position. Employees are held accountable for all duties of the job. Job duties and the % of time identified for any function are subject to change at any time.

Celestica is an equal opportunity employer. All qualified applicants will receive consideration for employment and will not be discriminated against on any protected status (including race, religion, national origin, gender, sexual orientation, age, marital status, veteran or disability status or other characteristics protected by law).

At Celestica we are committed to fostering an inclusive, accessible environment, where all employees and customers feel valued, respected and supported. Special arrangements can be made for candidates who need it throughout the hiring process. Please indicate your needs and we will work with you to meet them.

Company Overview

Celestica (NYSE, TSX: CLS) enables the world’s best brands. Through our recognized customer-centric approach, we partner with leading companies in Aerospace and Defense, Communications, Enterprise, HealthTech, Industrial, Capital Equipment and Energy to deliver solutions for their most complex challenges. As a leader in design, manufacturing, hardware platform and supply chain solutions, Celestica brings global expertise and insight at every stage of product development – from drawing board to full-scale production and after-market services for products from advanced medical devices, to highly engineered aviation systems, to next-generation hardware platform solutions for the Cloud. Headquartered in Toronto, with talented teams spanning 40+ locations in 13 countries across the Americas, Europe and Asia, we imagine, develop and deliver a better future with our customers.

Celestica would like to thank all applicants, however, only qualified applicants will be contacted.

Celestica does not accept unsolicited resumes from recruitment agencies or fee based recruitment services.