以上为北京时间。链接检查不代表仍在招聘,申请前请以招聘官网为准。
按这个岗位的城市和方向提醒,确认后才开启,可选择每日或每周。
该工程师负责生物相容性测试和材料分析工作,确保产品符合ISO 10993标准,进行材料表征、热分析等实验,并支持全球材料科学团队的标准化建设。
About SHL Medical
SHL Medical is the 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, with sites in Sweden, Taiwan, and the Unites States.
Job Overview
As a Biocompatibility / Materials Engineer, you will focus on biocompatibility tasks and the materials analysis. In this capacity, the engineer will deliver excellence in biocompatibility testing and materials regulation compliance, thereby enhancing product quality and understanding, as well as process efficiency and capability.
Additionally, this role also involves conducting studies to select suitable, sustainable materials that adhere to regulations and ISO requirements, as well as characterizing laboratory materials. The engineer will support the expansion of the Global Materials Science group by promoting global alignment on materials analysis and biocompatibility assessment.
Main Responsibilities
Biocompatibility
Participate as the project biocompatibility lead to ensure that SHL products are compliant with ISO 10993 standards and drive related reporting requirements.
Author test plans and technical reports on Biocompatibility of SHL products.
Author strategies to leverage current product compliance, toxicology and other materials
Part of the project team and contribute as a subject matter expert on ISO 10993 related matters.
Provide expert evaluations for materials regulatory topics, such as REACH, CP65, etc.
Materials Analysis
To play a vital role in materials analyses and in maintaining laboratory standard practices under ISO17025
Perform materials characterization and analysis as Tensile Testing and Impact Testing, and Thermal Characterization using Thermogravimetric and Calorimetric methods
Run independent research and development projects to expand the SHL knowledge base in various technical areas, especially Plastic Resins, materials performance, metals, molding process and sustainability
Technical and Documentation
Author technical documents
Contribute to process improvements to enhance operational efficiency, global alignment and standardization
Support vendor and external test lab communications, understand specifications, requirements and standards
Contribute as a vital project team member for DFx evaluations
Participate / Lead investigations into deviations and non-conformities
Reporting and Communication
Collaborate and drive cross-functional initiatives and communications
Present findings and make actionable recommendations (written and verbal) horizontally and vertically within and across departments to Global organizations
Support Global Materials Science globalization efforts, including test methods, documentation and best practices and standardization
Able to travel internationally occasionally
The responsibilities outlined above are not exhaustive and may evolve over time. Additional duties may be assigned as needed to meet the ongoing needs of the organization.
Minimum Qualifications
Bachelor's degree in Materials Science, Bioengineering or relevant Engineering / Science / technical discipline.
2-3 years related work experience in an analytical laboratory or technical role related to materials analysis, materials compliance and regulation
Knowledge in materials science (e.g. polymers, metallurgy), materials and chemical regulation and compliance
Team player and self-starter, able to perform with minimal supervision, proactive, hands-on-can-do attitude, persistent, results- and execution-oriented, able to work under pressure in changing environments
Willing to work in a laboratory environment
Preferred Qualifications (nice to have)
Experience and in-depth knowledge in Sustainable Materials, Materials analysis and regulatory affairs
Experience in basic data analysis, statistics, and technical writing
Experience with liaising with external testing labs or vendors.
Language skills
Must have: Excellent English communication (written, verbal) skills
We Offer:
Challenging assignments in a fast-growing and innovative industry.
A multicultural team and modern working environment with state-of-the-art facilities and technologies.
A place where we take pride in the inclusive and collaborative environment we have built - one where a true sense of belonging fosters meaningful exchange and shared growth.
Various opportunities for personal and professional development within a global organization.
Interested in joining SHL Medical and in supporting us with your expertise and personality? Then we look forward to receiving your application to our Talent Acquisition Department. For more information on SHL Medical, please visit: shl-medical.com/careers
Please note: We do not accept applications from recruitment agencies for this position.