***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&D Global Quality Operations (GQO) Regulatory and Marketing.
• Interpret assess analyze and apply international standards related to sterilization cleaning disinfection and biocompatibility. Mentor others.
• Support technical problems of significant scope and complexity; 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 products 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&D Quality Manufacturing Regulatory Clinical Marketing and Project Management to ensure project success.
• Identify and support the creation of or improvements to procedures policies processes systems and technology.
• Support and execute complex projects on multifunctional teams to advance projects through the design /development/launch process.
• Deliver high quality results with passion energy and drive to meet business priorities.
• Collaborate with cross-functional teams to build partnership to achieve business objectives.
• Demonstrated leadership and interpersonal skills with ability to effectively communicate and lead through influence

PREFERRED QUALIFICATIONS: What you will need (strongly desired):

Technical Skills:

• In depth technical knowledge and understanding of FDA GMP ISO and other medical device regulatory requirements.
• Adept at applying knowledge of cleaning disinfection and sterilization validation principles testing concepts standards and practices within a regulated environment.
• Strong technical expertise with multiple sterilization modalities (e.g irradiation ethylene oxide vaporized hydrogen peroxide moist heat)
• Adept at applying knowledge of biocompatibility requirements test methods and practices within a regulated environment.
• Adept at applying knowledge of environmentally controlled area qualification principles and monitoring requirements standards and practices within a regulated environment.
• Ability to communicate moderate complexity plans and technical information to team members.
• Strong technical ability to read and Interpret standards and regulations.
• Strong technical ability to analyze and interpret laboratory and validation test results and to resolve test failures.
• Working knowledge of business applications such as Microsoft Office.

• Preferred Skills:
• Exercise discretion and independence when applying professional expertise.
• Must be able to manage time projects stress and conflict.
• Must possess strong interpersonal skills including written and oral communication.
• Must be able to bring tasks through to completion with minimal supervision.
• Must have the ability to prioritize work and keep detailed and confidential records.
• Must be able to communicate / present to large groups of people.

Certifications:

• AAMI CISS certification desirable.

MINIMUM QUALIFICATIONS: What you will need (must have):

EDUCATION REQUIREMENTS

• Bachelor of Science in Biology Microbiology Chemistry or Biomedical Engineering.
• 4 years of work experience