Risk Analysis Engineer

Jobinhalt

About the job

SHL Medical AG is a world-leading solution provider in the design, development and manufacturing of advanced drug delivery systems with more than 5000 employees worldwide. Our customers include top pharmaceutical and biotech companies from around the globe that require innovative devices such as auto injectors or pen injectors to effectively deliver their drugs. Headquartered in Switzerland since late 2018.

Taiwan has been SHL’s starting ground in our bid for global mobility in the fields of drug delivery and medical technology. Our ambitious people who come from various cultures share the same aspiration – ensuring the right drug device for the delivery of modern precision medicine.

Job Overview

The objective of Risk Analysis and Management Engineer is to identify the characteristic related to the safety of the product, identification of hazards, and estimation of the risks for each hazardous situation and evaluation of the identified risks.

Main Responsibilities

• Support the creation of manufacturing and development control plan.
• Identify potential risks in the end to end development. Processes including material handling, transportation…etc.
• Create process Failure Mode and Effect Analysis (FMEA) for General and Project related processes to assess the potential risks for each piece of equipment used in the assembly/testing process and in-between processes e.g. handling between assembly area and warehouse.
• Review Design FMEA provided by the design office in order to understand the functionality and the potential risks engendered by the assembly of each component.
• Call cross-functional meetings including staff members from Automation, Design office, Project Management, Quality Assurance, Validation, etc. to communicate all open items from the FMEA reports and discuss solutions to mitigate the risks.
• Attend Nonconforming Material Report (NCMR) and Complaint meetings relevant to one’s scope and update FMEA report when judged necessary by the project team.
• Attend f2f and phone meetings, and project related workshop with overseas colleagues as well as customers

Required Skills & Qualifications

• Compliant to ISO 13485 standard with Risk management approach
• Logic thinking and good communication skill with varying technical experts
• Great Root cause analysis skills
• Strong on Writing/Reading in English (TOEIC:500)

We offer

• Competitive compensation package.
• Modern & variety of culture working environment with state-of-the-art facilities and technologies.
• Challenging assignments in a fast growing and innovative industry.
• Position in a dynamic, international team of highly skilled professionals.
• Various opportunities for personal and professional development within a global organization.

Apply for this Job

Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application including CV and all other relevant documents.

For more information on SHL Medical, please visit our website: www.shl-medical.com

Is this not quite what you are looking for? Further interesting career opportunities can be found on our SHL Career page: www.shl-medical.com/careers

Please note: For this position we do not consider applications from recruitment agencies.