Overview
Remote
To define
Full Time
Skills
Product Development
Biomedicine
Testing
Analytical Skill
Biomedical Engineering
IT Project Management
Medical Devices
Software Development
Quality Management
QMS
Project Planning
Product Requirements
Use Cases
Quality Assurance
Risk Management
Product Design
Regulatory Compliance
Design Controls
Documentation
ROOT
Failure Analysis
Auditing
Policies and Procedures
Supervision
Systems Engineering
ISO 9000
Project Management
Communication
Training
Agile
Software Development Methodology
Insurance
Job Details
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 Better . 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 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.
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.
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 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.
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.