Equipment Engineer II (Calibration), CRM

Equipment Engineer II (Calibration), CRM

As one of the world´s leading manufacturers of cardio- and endovascular medical devices, BIOTRONIK is headquartered in Berlin, Germany, and represented in over 100 countries by its global workforce. The work of our committed, highly specialized, exceptionally skilled employees results in crucial advancements in the world of cardiology and changes the lives of patients every day.

The Equipment Engineer II (Calibration) is responsible, as member of the interdisciplinary operation team, to provide technical support for production operations in meeting output and quality. This includes inspection, test, maintain and repair a variety of electrical/mechanical equipment to ensure measurement accuracy. His/her expertise will be required to setup and maintenance of the calibration lab.

Your Responsibilities

• Create and update process calibrations plans in SAP and timely execution of the activities.
• Accountable for maintaining the Quality calibration documents.
• Day-to-day duties and responsibilities to use various tools to calibrate electrical, mechanical and electronic instruments and equipment.
• Analyze test data to make decisions about the need for calibration, repair, and maintenance.
• Prepare calibration certificates, test reports.
• Performs preventative and corrective maintenance of test apparatus and peripheral equipment.
• Provide calibration training for equipment technicians on calibration activities.
• Collaborate with engineers and production in continuous process improvement projects.
• Provide expertise support during internal/external audits.
• Working closely with clients and cross-functional departments to communicate project statuses and proposals.
• Maintain and build up relationships with local vendors.
• Involve directly on the Total Productive Maintenance (TPM) system, work closely with team members on maintaining and improving performance of equipment to enhance safety and process capability.
• Train and educate operators, technicians and engineers.
• Able to travel as necessary.

Lean Manufacturing:

• Statistical Process Control (SPC).
• Process / Machine Capability Studies (Cp, Cpk / Pp, Ppk).
• Total Productive Maintenance (TPM) concepts.
• 5S, 7-Mudas and Kaizen methodologies.

Continuous Improvement Project Management:

• Failure Mode Effects Analysis (FMEA) and Product Risk Analysis (PRA)
• Root Cause Analysis tools to identify and resolve problems
• JDI (Just-Do-It), PDCA (Plan-Do-Check-Act) and A3 Problem Solving as project initiative to address equipment issues

Calibration Skills:

• Develop calibration training and procedures according to standards.
• Adopt new technologies to improve calibration methods and equipment system.
• Performed technical work on equipment such as calibration, repair, assembling and testing activities.
• Basic understanding and interpretation of electrical, mechanical and pneumatic drawings.
• Basic understanding of ISO 17025.

Your Profile

• Degree/Diploma in the field of Mechanical, Electrical, Bioengineering discipline.
• Degree holders: at least 2 years of relevant working experience.
• Diploma holder or equivalent: At least 8 years of relevant working experience.
• Experience calibration role in a regulated environment (eg: medical devices, aerospace industry).
• Prior work experience in a technical area with strong affinity for calibration activities.
• Exposure to a GMP and ISO17025 regulated environment will be an advantage.
• Experience in high volume manufacturing and assembly processes.
• Excellent interpersonal skills with a strong systematic mind set.
• Prior experience in Total Productive Maintenance (TPM) will be an advantage.
  

What we offer

• Being encouraged to think and act entrepreneurially.
• Working in global teams and projects.
• Developing yourself professionally.

Are you interested? Please apply online through our application management system! We are looking forward to welcoming you.

Location: Singapore | Type of contract: Full-Time

Apply now under: www.biotronik.com/careers

Job ID: 58120 | Contact: Human Resources

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity or expression, national origin, disability status, protected veteran status, genetic information, or any other characteristic protected by law.