Principal Systems Requirements Engineer

Position Overview:

Help write, organize and maintain requirements, tests, and risk assets within our ALM system

Duties and Responsibilities:

• Migrate content of all projects to the new Cockpit environment.
  • Convert Requirements and Tests from older environments to the new environment
  • Help transition current Risk assets to Cockpit
  • Partner with functional owners of documents to help them meet their deliverables.
  • Work with teams to ensure the correct information is entered into Cockpit.
  • Create drafts of documents and then either pass along to engineer to complete or maintain ownership and work with engineer to complete.
  • Lead document reviews, consolidate redlines, and facilitate discussions about documents.
  • Use personal knowledge to ensure documents meet design assurance and regulatory requirements.
  • Export documents from Cockpit and prepare them for submittal to Windchill 10.
• Standardize documentation across projects.
  • Depending on how detailed the corporate templates already are, add boilerplate wording to templates to ensure document consistency across teams and reduce writing time (e.g., add division-specific wording to corporate templates such as purpose statements, build requirements, etc.).
  • Standardize, organize and maintain configuration data within Cockpit.
  • Give input to corporate about how well templates are working for the teams.
  • Create/maintain libraries of standard information: 1) sources, reference documents, etc. (linked, so updates would carry through to documents), and 2) rationales, justifications, etc. (copied to document to give a place to start; not linked, so updates would not carry through to documents).
• Work closely with core teams to determine documentation strategy.
  • Be familiar with what documentation deliverables are required for each phase of PLCP.
  • Work closely with project managers to determine documentation timing - when things need to be started/finished (share knowledge from past experiences).
  • Guide teams in documentation strategy using knowledge of other projects.

Desirable Traits:

• Customer first attitude: always be available to help the users of our tools
• Ability to develop and maintain good relationships with R&D teams to quickly assess their needs and implement solutions for these needs.
• High standards for quality of work
• A strong interest in continuous learning about and adaption of new technologies and methodologies
• High level of organizational skills and attention to detail

• Strong knowledge of medical device development processes and documentation required for regulatory submissions

Basic Qualifications:

4 year degree

7+ years' experience in medical device industry

EOE Statement: Specialist Staffing Group is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.

In addition to base pay, employees may be eligible for benefits such as health insurance, health savings accounts, retirement savings plans, life and disability insurance, and paid leave where required by applicable law. Eligibility may vary based on factors such as location and hire date and is subject to change.

To find out more about Real, please visit www.realstaffing.com