Document Control Specialist / Engineering Analyst I

Job Title: Document control specialist / Engineering Analyst I

Duration: 6 months Contract

Location: San Diego, CA.

• Job Title: Analyst I, Requirements Analyst
• Location: San Diego, CA, US (Hybrid preferred)
• Job Type: Contractor (6 months)
• Department: Systems Engineering

Job Summary

• The Requirements Analyst will support various PLM, ALM, and SAP-related activities for several sustaining engineering and some new product development projects.
• This role will collaborate with the required document owners to make changes to design control documentation and data via document management processes according to the QMS.
• Associate will work closely with R&D engineering, marketing, operations, manufacturing plants, quality, medical affairs, and regulatory affairs functions.
• The role will require strong cross-functional collaboration, communication, organization, and time management skills.
• This job opportunity is heavily reliant on the ability to manage data and produce deliverables that are dependent on various product and project specificities.
• There is a heavy need on producing accurate and time-sensitive deliverables, with a focus on cross-functional collaboration between multiple teams and stakeholders, database and document remediation, process improvement, and data integration with proper alignment.
• A successful candidate will quickly become comfortable working with new and unfamiliar systems, have the capacity to operate a multitude of work items simultaneously, and effectively coordinate work requests across functional team members.

Key Responsibilities

• Manage Requirements, Specifications, User Needs, Hazards, and other controlled documents within DOORS database (e.g. create, update, link, data alignment, and maintain)
• Produce PRDs, Specs, RTMs, and a surplus of interim exports daily
• Function as DOORS test administrator for the creation of VVP and VVR
• Apply product and project knowledge to harmonize discrepancies across different deliverables
• Support audits in finding unclear or missing information found in interconnected documents
• Collaborate all DOORS-associated documents in SAP following data transcription
• Assist with data migration activities between DOORS and Polarion, and document migration between SAP Tahiti and Teamcenter as needed
• Assist teams with DOORS support functions including installation, user accounts, and system updates
• Ensure projects and initiatives are delivered, providing consistent and effective communication on status and managing escalation and avoiding risk

Minimum Qualifications

• Bachelor's degree or higher in Information Technology, Engineering, Computer Science, or a related field is strongly preferred
• Minimum 1-3 years of experience working with database management, engineering documentation, technical writing, or demonstrated capability
• Proficiency in Microsoft applications is required (Excel, Word, PowerPoint, Outlook)
• Experience working in a healthcare or medical device development environment is preferred
• Experience with ALM/PLM tools is preferred (SAP, IBM DOORS, Teamcenter, Polarion)
• The candidate must be legally authorized to work in the US

Other Required Skills

• Positive attitude with an aptitude for multitasking and critical thinking
• Excellent written communication skills in English; strong interpersonal skills
• Robust organizational skills; able to manage complex details and multiple synchronous tasks with an emphasis on quality and efficiency
• Able to work independently and with a group, manage time effectively, and prioritize workload
• Willingness to learn and adapt to new challenges, processes, and technology