Nesco Engineering and IT is currently seeking a Software Project Coordinator, Senior for a contract opportunity in Tucson, AZ.
The ideal candidate will have subject matter expertise on Product Development Process (PDP) and Work Instructions (WIs). They will also participate in project planning and advise project leadership on best practices, tailoring of deliverables, timelines, and risks for the given project type.
Essential Functions: Accountable for identifying, planning, and tracking documentation deliverables according to the PDP and WIs, for each project milestone. Identifies the correct authors, reviewers, and approvers for various document deliverable types.
Coordinates with cross functional group (Quality, Architecture, Requirements, Development, Test, Support, etc.) to monitor deliverable status, and drives timely approvals per project schedule. Addresses dependencies and removes bottlenecks.
Reports status and risks to project leadership.
Manages workflows: Design Change Orders (DCOs), Document Changes (DCs), and Product Development Process Document Approvals (PDP DAs) via the Document Control System (DCS). Ensures that updated documents adhere to correct templates and versions according to current WIs.
Facilitates review meetings for project milestones. Records meeting minutes, decisions, and action items. Drives action item completion.
Ensures consistency and alignment across Software project teams and facilitates quarterly update meeting.
Works with Development Quality and Software project teams to ensure dFMEA is up to date and complete. Collaborates with project teams to create and/or maintain dFMEA's and other failure/fault analysis documents.
Manages and maintains Software Design History File (DHF) in the DCS. Organizes documentation deliverables per best practices. Ensures DHF consistency across Software projects.
Liaise with Quality and Development functions to ensure that potential future changes in templates/planned document deliverables are considered in project documentation plan(s). Helps ensure that potential future changes in templates align with document generation tools (i.e. HQC ALM DocGen).
Actively participates in WI and template reviews. Recommends process improvements based on feedback and experience.
Promotes good documentation practices and use of the R&D Software Department Wiki. Creates, standardizes, and maintains articles in the wiki.
Skills: Familiarity with regulations and standards such as 21 CFR Part 820 (820.30 Design Control), ISO13485, ISO 14971, IEC 62304 and IVDR are preferred, but not required.
Strong organizational skills and ability to manage multiple concurrent projects.
Ability to plan project components and effectively report status to stakeholders.
Knowledge of creating software documentation for a medical device.
Ability to understand and improve highly complex software documentation structures using tools such as HPALM, Excel, etc.
Ability to work across the organization, with a high degree of interaction, to confirm that software documentation is complete and consistent with work products from other engineering functions.
Ability to create project documentation that is complete, consistent, and accurate.
Proficient in document control system(s).
Strong written and verbal communication skills.
Understanding or familiarity with project management tools (such as SmartSheets, MS Project, or Trello).
Education and Experience: Bachelor's degree in related discipline or equivalent combination of education and experience.
6 years of related experience, preferably in a regulated industry
For immediate consideration you may contact Sarah Bergeron directly at , or click on 'Apply Now' to submit your resume.
Nesco Resource and affiliates (Lehigh G.I.T Inc, and Callos Resource, LLC) is an equal employment opportunity employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, age, or veteran status, or any other legally protected characteristics with respect to employment opportunities.