A renowned, leading Medical Device company currently has an opportunity for a Packaging Development Engineer to join their team in Switzerland. Within this technical leading role, you will be responsible for driving development projects and activities for both sterile barrier and nonsterile barrier packaging from the idea to the market.
- Represent the packaging subject matter expert and be the point of knowledge for the entire product packaging and its demands to compliance with all relevant regulations, guidelines and procedures
- Design and develop technical concepts and layouts for entire packaging solutions considering applicable design requirements, the necessary equipment and processes
- Provide packaging related engineering support for corporate projects to enable the launch of new or revised products and provide subject specific service to the involved departments
- Perform and report technical packaging analysis, feasibility studies and design verification tests for performance & stability and material & sterilization compatibility according to recognized test methods
- Generate and review technical specifications as part of Technical Files ensuring these documents are accurately and comply with applicable engineering, medical device and our clients standards
- Analyze, improve and write standard operating procedures or work instructions
- Conduct corporate- and supplier audits as SME and advise manufacturing sites
- Support quality projects and CAPAs related to the packaging design
Education, Skills and Experience:
- Technical University degree (MEng, BEng or equivalent) in relevant fields, e.g. packaging- or mechanical engineering, materials sciences or equivalent
- 5+ years of successful work experience in the design controlled packaging development field with an outstanding track record as project leader in the medical device- or pharmaceutical industry
- Profound knowledge of the design control process as well as applicable regulations, standards and directives like ISO 11607-1, 21 CFR 820.30/130, ISO 13485, ISO 9001, MDD 93/42/EEC
- Good understanding of user needs, clinical and laboratory workflows to efficiently translate customer needs into technical solutions
- Strong organizational skills with the ability to prioritize and accomplish single tasks of simultaneous projects meeting committed objectives and timelines
- Strong analytical skills and result orientation with interest into innovation and new technologies
- Comprehensive knowledge in relevant software tools (SAP, MS Office etc.)
- Fluent in spoken and written English, German is an asset
- Willingness to travel (approx. 5-10%).
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Alexander Tooulas on +44 203 3193 032 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.