Engineer Sr. I, Software Quality - ACT (Remote)

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. Arthrex is actively searching for an Engineer Sr. I, Software Quality – ACT who is responsible for oversight of quality and risk management throughout the software lifecycle, and independently audits the adequacy of design specifications, Verification &Validation test plans, and reliability test plans for products. The Sr. Engineer participates with cross-functional teams with other business and engineering disciplines, establishes the principles of product and service quality evaluation and control for the system.  Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

This position is eligible for remote work.

Essential Duties and Responsibilities:

• Ensures that appropriate Software (SW) Quality plans are made that include all stages of the software life cycle and supports SW Quality Plan design.
• Validates key design inputs (i.e. usability, reliability, performance, supportability, manufacturability, localizability, safety, security, privacy, serviceability, sustainability and costs).
• Provides effective oversight of the execution of the SW Quality Plan and any Risk Management activities, and of all design related activities during the software lifecycle.
• Can lead quality related problem solving for software.
• Use post-market analytics and statistics to report on software performance in the field (provide feedback to manufacturing, suppliers or design teams) and initiate field actions as necessary, as required.
• Act as a business partner, single point of contact (person assigned to project team) responsible to ensure that software design quality related requirements/criteria are completed and meet SW Quality standards.

Education and Experience:

• Bachelor’s Degree in Computer Science or Engineering related discipline required.
• Strong Knowledge of ISO 13485, MDSAP, IEC 62304, IEC 62366.
• Experience with internal and external quality audits.
• 5+ years of related experience in a medical device or regulated industry preferred.
• Experience with SDLC for software in medical devices (SiMD) and software as medical devices (SaMD).
• Working knowledge of appropriate global regulations, requirements, and standards for Software in medical devices and Software as Medical Device, including Machine Learning / Artificial Intelligence solutions.
• Knowledge on Augmented Reality (AR) in Medicine.
• Experience with Software Risk Management.
• Experience with Agile Methodology and different SDLC.
• Experience with JAMA, Jira, Confluence, CI/CD and DevOps, SAP, Agile tools such as: configuration management, source control, unit testing, etc.

Knowledge and Skill Requirements/Specialized Courses and/or Training:

• Working knowledge of the Software Development Life cycle.
• Solid understanding of programming languages.
• Demonstrated ability to document test plans, test cases, test results
• Demonstrated problem-solving, organizational, and analytical skills.
• High attention to detail and accuracy.
• Leadership skills with the ability to provide quality guidance to software engineering partners.
• Excellent communication skills, presentation skills, and a customer service orientation.

Machine, Tools, and/or Equipment Skills:

PC servers, workstations, and laptops. Microsoft environment. Work with standard current computer applications, such as word processing, spreadsheets, and databases.

Reasoning Ability:

Ability to define problems, collect data, establish facts, and draw valid conclusions.  Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Mathematical Skills

Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.

Language and Communication Skills:

Ability to comprehend and apply language skills to the degree required to perform the job based upon the job requirements listed above. Ability to verbally communicate ideas and issues effectively to other team members and management. Ability to write and record data and information as required by procedures.

Arthrex 2023 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
• Gym Reimbursement Program
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• 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 or protected veteran status.