Work Flexibility: Hybrid ***15 months fixed term contract*** Position Summary: The Staff Scientist will be responsible for providing technical support to various areas of the business including biocompatibility, cleaning, disinfection, and sterilization of reusable and single use medical devices.
Technical Responsibilities: Independently develop compliant testing protocols and guidelines and support regulatory submissions for new product development and product changes of both terminally sterilized and reusable medical devices.
Independently coordinate and complete project deliverables in collaboration with cross functional groups such as R independently determine and develop approach to solutions.
This may include support for quality issues such as customer complaints, adverse events, product field actions, and non-conformances.
Perform gap assessments to new or changing standards and mentor others.
Lead the development or revision of quality system procedures for Clinical Sciences.
This may include serving as a divisional process owner (DPO).
Support internal and external regulatory audits as an SME.
Participate in Corporate wide projects or initiatives; this may include Corporate quality system workgroups.
Support Regulatory Affairs in interactions with FDA or Competent Authorities on topics pertaining to Clinical Sciences Train, provide direction and technical support to junior team members Support internal and external customer inquiries Business Responsibilities: Advance solutions by applying in-depth knowledge of customer needs, design inputs and technical areas of responsibility.
Apply detailed knowledge of with product's intended use, clinical procedures, and manufacturing process.
Demonstrate developing financial acumen.
Apply knowledge of how test strategies impact development timelines and cost.
Apply awareness of cultural differences that may exist in business practices in global interactions and mentor others.
Med Device Compliance: Be proficient with and mentor others in usage of industry standards, including validation requirements and test strategies per applicable regulations.
Lead creation and refinement of documentation, such as sterilization evaluations, biocompatibility evaluations, and reusable device processing evaluations, per company design control procedures.
Follow and mentor others on procedures like terminal sterilization, biocompatibility evaluation, and reusable device processing, per the Quality Management System.
The role may include support of national and/or international standards committees and workgroups.
General Responsibilities: Work cooperatively with R