Scientist, Design Control and Risk Management - Data Management (Hybrid)

Job Description

As a Design Control and Risk Management Data Manager, you are a key member of the Device Development Team. Your will main responsibility is to develop and manage the data relationships through the development and life cycle of a product.  

Key responsibilities include the following:

• Partner with the Design Control and Risk Management leads to determine the data relationships and mapping.

• Lead data review meetings with content owners and Quality.

• Create and manage data linkages and relationships.

• Manage open deliverables and tasks.

• Manage the Global Design File from concept, launch and post market.  

• Support second person review with source data for regulatory filing.

• Support Design Transfer and Manufacturing readiness.

• Manage data management approval workflows.

• Support impact assessments for design changes during development and post market.

• Utilize library data to drive cross project consistency.  

• Become the IT system SME and trainer.

• Drive continuous process improvements.

• Management updates to data and templates.

Basic Qualifications:

• Bachelor’s degree in a Science, Technology, Engineering, or Math (STEM) field

• 2-3 years in the medical device or pharmaceutical industry. 

Additional Skills & Preferences:

• Demonstrated ability work multi-functional teams, work effectively across boundaries, and to effectively influence without authority

• Strong collaboration skills and ability to work productively in an interdisciplinary environment.

• Integrated technical knowledge for IT system.

• Excellent written and verbal communication skills, able to effectively interact at all levels of the organization - business leaders, senior technical/scientific personnel, internal/external customers/suppliers/teammates

• Strong project management skills.

#EligibleForERP

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders).  Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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