Biomedical Engineer - Software Systems

Responsibilities

• Supports Software Development Life Cycle (SDLC) of software projects/programs.
• Supports the establishment of design inputs and 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, design and development plan, and specifications including transferring the product requirements to software use cases and acceptance criteria, collaborating on software test plans, assessing risk profiles, supporting risk management file creation, creating validation protocols, leading design reviews and phase gate closures, and sequencing project elements and discrete tasks.
• Assists in maintaining software project schedules by monitoring project progress, coordinating activities, and resolving obstacles through cross-functional collaboration across multiple time zones.
• Provisions tradeoffs between performance, cost, risk, and schedule.
• Participates in the review of design verification plans and procedures.
• Creates and maintains software product Design History Files (DHF) and helps coordinate all required activities with regulatory, quality, operations, and compliance teams.
• Ensures completion of Design Control Documentation.
• 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.
• Sets up and manages project milestones and deliverables.
• Works closely with cross-functional teams to ensure successful project execution.

Requirements

• Bachelor's degree in Biomedical Engineering strongly preferred.
• Strong technical project management skills will be essential for this position.

Qualifications

• Engineer 2 level: (Range $94 - 140K)
• Experience supporting complex, cross functional teams independently required.
• Experience participating in strategic discussion that addresses both business and technical risks required.
• Knowledgeable of application of systems engineering required.
• Knowledgeable of basic FDA and ISO guidelines for the development of medical grade software required.
• Project management and communication skills training preferred.
• Software agile (SDLC) process knowledge preferred.
• Sr 1 Engineer level: (Range $115 - 170K)
• Ability to lead complex, cross functional teams required.
• Experience contributing to strategic discussions that address both business and technical risks required.
• Knowledgeable of application of systems engineering to the medical software industry required.
• Knowledgeable of FDA and ISO guidelines for the development of medical grade software required.
• Strong project management skillset required.
• Strong technical communication skills required.
• Software agile (SDLC) process knowledge preferred.
• Technical knowledge in development methodologies, design, and project implementation preferred.
• Historical perspective on orthopedic surgery principles, theories, and products preferred.
• Sr 2 Engineer level: (Range $136 - 190K)
• Experience leading complex, cross functional teams independently.
• Experience leading strategic discussion that addresses both business and technical risks.
• Experienced in the application of systems engineering to the medical software industry required.
• Knowledgeable of FDA and ISO guidelines for the development of medical grade software required.
• Strong project management skillset required.
• Strong technical communication skills required.
• Deep understanding of Software agile (SDLC) process required.
• Deep technical knowledge in development methodologies, design, and project implementation required.
• Historical perspective on orthopedic surgery principles, theories, and products preferred.