Work Flexibility: Hybrid or Onsite

18 month contract with full benefits.

Hybrid role- 2 days a week onsite

POSITION SUMMARY:

The Sr. 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.

What you will do:

• Lead development of compliant testing protocols and guidelines and support regulatory submissions for new product development and product changes of both terminally sterilized and reusable medical devices.
• Support Business Development/Acquisition reviews as an SME.
• 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.
• Provide solutions to a wide range of 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.  Advise junior SMEs.
• 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.
• Independently support Regulatory Affairs in interactions with FDA or Competent Authorities on topics pertaining to Clinical Sciences.
• Apply and mentor others on advanced technical principles, regulations, and concepts.
• Lead responses to  internal and external customer inquiries.

General Responsibilities:

• Work cooperatively with R&D, Quality, Manufacturing, Regulatory, Clinical, Marketing and Project Management to ensure project success.
• Identify and lead the creation of or improvements to procedures, policies, processes, systems, and technology required.
• Contribute to complex projects on multifunctional teams and lead one technical area of expertise.
• Hold self and others accountable to deliver high quality results with passion, energy and drive to meet business priorities.
• Mentor, develop and inspire others in current and future roles.
• Collaborate with cross-functional teams to build partnership to achieve business objectives.

What you will need:

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

Travel Percentage: 10%