Requisition ID : 61862 Title: Biomedical Engineer - Software Systems1 Division: Arthrex, Inc. (US01) Location: Santa Barbara CA Salary Range:Salary Minimum: $92,000.00 Salary Maximum: $120,750.00
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 to work directly with the Engineering departments within Arthrex. You will get to s upport 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, 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™.
Essential Duties and 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 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 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.
Education and Experience:
High school diploma or equivalent required.
Bachelor's degree in a related field preferred.
relevant work experience preferred.
Experience supporting complex, cross functional teams independently preferred.
Experience participating in strategic discussions that address both business and technical risks preferred.
Knowledge and Skill Requirements/Specialized Courses and/or Training:
Knowledgeable of application of systems engineering preferred.
Knowledgeable of basic FDA and ISO guidelines for the development of medical grade software preferred.
Project management and communication skills training preferred.
Software agile (SDLC) process knowledge preferred.
All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.
