Job Information
Arthrex California Inc. Software Systems Engineer 1 in Santa Barbara, California
Essential Duties and Responsibilities:
- Supports Software Development Life Cycle (SDLC) of softwareprojects/programs.
- Supports the establishment of design inputs and/or system level software requirements, ensuring compliance to Arthrex Quality Management System (QMS) and global standards and regulatory requirements.
- Participates in the development of project plan and specifications including transferring the product requirements to software use cases and stories, designing the software test plans, assessing risk profiles, supporting risk management file creation and sequencing project elements and discrete tasks.
- Assists in maintaining software project schedules by monitoring project progress, coordinating activities, and resolving obstacles.
- Provisions tradeoffs between performance, cost, schedule. Participates in the review of design verification plans and procedures.
- Maintains software product Design History Files (DHF) and helps coordinate all required activities with regulatory, quality and compliance teams.
- Ensures completion of Design ControlDocumentation.
- Participates in the review of software product complaints and performs root cause failure analysis. Identifies and pursues novel technology to support future strategic opportunities.
- Supports Quality System Audits conducted by external agencies, such as FDA, Notified Body and/or Regulatory Agency audits.
- Ensures alignment of internal and externalcustomers.
- Solves routine problems of limited scope and complexity following established policies and procedures. Works under general supervision.
- Travel up to 10-15% domestically andinternationally.
Education and Experience:
High school diploma or equivalent