Who we want:
Applicants would ideally have native-level proficiency speaking and writing in German.
Hybrid role
Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.
Self-directed initiators. People who take ownership of their work, results-oriented, and need no prompting to drive productivity, change, and outcomes.
Team-players. People who can collaborate globally and thrive when developing lasting interpersonal relationships.
What you will do:
Lead new product development and/or changes to medical devices currently on the market for sterilization and/or biocompatibility.
Lead technical assessments, evaluate data, and present results to cross-functional team.
Lead departmental initiatives including setting timelines and milestones.
Write and present technical and scientific documentation
Maintain communications with internal customers.
Partner with cross functional teams including (RA, AO, Ops) to ensure business unit project timelines are met.
Partner with team by contributing to the development, maintenance, and improvements of the policies and procedures related to sterility and biocompatibility.
Act as subject matter expert to align to best practices, benchmarking against industry leads and regulatory requirements.
Lead root cause analysis, problem solving, and out-of-specification investigations.
Define validation activities (i.e. product adoptions, testing plans, etc.).
What you need:
BS in Microbiology/Biology/Chemistry or related discipline required; MS in Microbiology/Biology/Chemistry or related discipline preferred
4+ years of medical device, pharmaceutical or chemical industry
Native-level German skills required both written and verbal
Knowledge of GDP, ANSI, AAMI, ISO, FDA, EPA, and USP guidelines related to sterility and/or biocompatibility assessments (i.e. ISO 10993, ISO 11137, ISO 17665 etc)
Demonstrated ability to effectively communicate, manage projects, and influence as well as can prioritize and manage multiple tasks simultaneously.
Ability and desire to work effectively in a fast-paced multi-disciplinary team environment.
Strong interpersonal skills including strong written and oral communication.
Strong in critical and analytical thinking.
Highly developed problem-solving skills.
Demonstrated ability to write technical documentation.
Demonstrated ability to successfully manage and complete projects in a matrix organization.
We believe that all people are capable of great things. Because of this, we encourage you to apply even if you do not meet all of the requirements that are listed within this job description.
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Travel Percentage: 10%