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    Software Systems Engineer 1 - Goleta, United States - Arthrex

    Arthrex
    Arthrex Goleta, United States

    2 weeks ago

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    Description

    Arthrex, Inc. is a global medical device company and a leader in new product development and medical education. We are a privately held company that strives to accomplish our corporate mission of Helping Surgeons Treat Their Patients BetterTM. We are committed to delivering uncompromising quality to the health care professionals who use our products, and ultimately, the millions of patients whose lives we impact.

    Arthrex Benefits

    Medical, Dental and Vision Insurance
    Company-Provided Life Insurance
    Voluntary Life Insurance
    Flexible Spending Account (FSA)
    Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
    Matching 401(k) Retirement Plan
    Annual Bonus
    Wellness Incentive Program
    Free, Onsite Medical Clinics
    Free Lunch
    Tuition Reimbursement Program
    Trip of a Lifetime
    Paid Parental Leave
    Paid Time Off
    Volunteer PTO
    Employee Assistance Provider (EAP)

    Please note, most benefits are for regular, full time employees.

    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.



    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 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, Bachelor's degree in Biomedical Engineering strongly preferred, strong technical project management skillswill be essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients BetterTM.

    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.

    Arthrex Benefits

    • Medical, Dental and Vision Insurance
    • Company-Provided Life Insurance
    • Voluntary Life Insurance
    • Flexible Spending Account (FSA)
    • Supplemental Insurance Plans (Accident, Cancer, Hospital, Critical Illness)
    • Matching 401(k) Retirement Plan
    • Annual Bonus
    • Wellness Incentive Program
    • Free Onsite Lunch
    • Gym Reimbursement Program
    • Tuition Reimbursement Program
    • Trip of a Lifetime
    • Paid Parental Leave
    • Paid Time Off
    • Paid Sick Leave
    • Volunteer PTO
    • Employee Assistance Provider (EAP)

    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.

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