Engineer II, Risk & Post Market Surveillance

Work Schedule

Environmental Conditions

Job Description

At Thermo Fisher Scientific team youll discover impactful work innovative thinking and a culture dedicated to working the right way for the right reasons - with the customer always top of mind. The work we do matters like helping customers find cures for cancer protecting the environment making sure our food is safe and delivering COVID-19 solutions. As the world leader in serving science with the largest investment in R&D in the industry our colleagues are empowered to realize their full potential as part of a fast-growing global organization that values passion and unique contributions. Our commitment to our colleagues across the globe is to provide the resources and opportunities they need to make a difference in our world while building a fulfilling career with us.

Location/Division Specific Information

Position: 1 year fixed term parental cover

Position Location: Basingstoke

Direct Report To: Risk and PMS Manager

Group/ Division: MBD

Discover Impactful Work:

Reporting to the Risk and PMS Manager the successful applicant will join Risk and PMS team working closely with Microbiology Division sites to support collation of the risk management files and PMS files for the portfolio.

A day in the Life:

• Senior role coordinating activities to assist the team in compilation of Post Market Surveillance reports and Risk files reviewing files to ensure a high level of quality.
• Act as the Senior Risk & PMS representative on subject matter expert (SME) calls and metric update meetings to communicate file progression timeline risks or critical issue points.
• Identify and mitigate Risk & PMS file content or timeline risks and issues implementing contingency plans as vital to ensure they are delivered within the required timelines.
• Participate in Practical Process Improvement (PPI) projects to streamline and automate the file collation process and with other specific results.
• Collate and input data to measures and indicators to support dedicated performance and continuous process improvement culture.
• Input into relevant processes and standard operating procedures (SOPs) as required.
• Similar Devices Database Identify similar devices and keep the database up to date.
• Providing proactive PMS data - including generating capturing collating and managing of Key competitor information customer feedback and sales volumes.
• Data analysis and interpretation of trends and changes from a marketing perspective.
• Performs other work-related duties as assigned.

Keys to Success:

Education

• Bachelor degree preferred.

Experience

• Microbiology or In Vitro Medical Device product knowledge or Quality Assurance experience preferred.
• Previous experience of technical scientific writing documenting processes with strong analytic and problem-solving abilities.

Knowledge Skills Abilities

• Very good interpersonal skills to develop and communicate ideas and insights results and recommendations across multiple SME teams (without direct authority) in a simple easy-to-understand delivery.
• Excellent planning and time management with the ability to adapt to rapid changes in priorities and meeting timelines.
• Shown ability to lead projects preferably in a scientific or manufacturing environment.
• Ability to lead and analyse customer feedback data and trends in the market as well as basic statistical skills.
• Interest in PPI and automation.
• Ability to work both independently and as a team member.
• High attention to detail.
• Excellent oral and written communication skill.
• Proficient in the use of Microsoft Office SAP and standard computer applications. Power BI experience preferred.
• Role model demonstration of the companies 4i values.

Physical Requirements / Work Environment

• Desk based role

Benefits

We offer competitive remuneration annual incentive plan bonus healthcare and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture that stands for integrity intensity involvement and innovation.

Our Mission is to enable our customers to make the world healthier cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100000 colleagues we share a common set of values - Integrity Intensity Innovation and Involvement - working together to accelerate research solve complex scientific challenges drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific where diverse experiences backgrounds and perspectives are valued.

Apply today!

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other legally protected status.

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