Biomedical Engineer - Software Systems II

Arthrex

About The Position

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively seeking an Biomedical Engineer - Software Systems II to work directly with the ADI Engineering department within Arthrex. You will get to support full life cycle development of software applications, which includes initiation, design, development, verification/validation, release, deployment and maintenance. Responsibilities include defining software acceptance criteria, application of systems engineering with knowledge of basic FDA and ISO guidelines, project management, design history file creation, and design assurance testing support. Excellent communication and analytical skills required, Bachelor's degree in Biomedical Engineering strongly preferred, strong technical project management skills will be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

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.
High school diploma required
2 years of relevant work experience required

Nice To Haves

Bachelor’s degree in a related field preferred
Bachelor's degree in Biomedical Engineering strongly preferred
strong technical project management skills will be essential for this position
Project management and communication skills training preferred.
Software agile (SDLC) process knowledge preferred.

Responsibilities

Supports Software Development Life Cycle (SDLC) of software projects/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, 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.
Ensures alignment of internal and external customers.
Solves routine problems of limited scope and complexity following established policies and procedures. Works under general supervision.
Travel up to 10-15% domestically and internationally.