Operations Software Developer I - SC

Main Objective:

Software design and development to support Arthrex mission in “Helping surgeons treat their patients better”.

Essential Duties and Responsibilities:

• Responsible for software development life cycle for both new applications and modifications to existing ones
• Participates in gathering user/customer functional requirements
• Programming using C#, Ruby, JavaScript, SQL, Java, .Net, C++ and other similar languages
• Familiar with machine protocols MTConnect, Modbus, MQTT, TCP/IP, and other similar protocols
• Analyze business process potentials for streamlining and improvements in efficiencies
• Develop Application Design Specifications, Test and Acceptance Plans, Software testing and code review
• Project management of software validation activities and deliverables
• Ensure validations are compliant with appropriate regulations, such as ISO CFR 21 Part 11, 820 and cGMP regulations, and corporate policy
• Maintain current with ISO/FDA and internal quality assurance policies
• Responsible for documenting and validating new applications and modifications to existing ones
• Participates in gathering user/customer functional requirements
• Develop/estimate project schedules/tasks based on requirements
• Programming using a variety of languages for controlling and monitoring manufacturing and inspection equipment
• Analyze business process potentials for streamlining and improvements in efficiencies through value stream mapping and documented data/process flows
• Prepare, assist, or participate in system design, specification development, and design review of control systems hardware and software for manufacturing and inspection equipment
• Assess the impact of system changes thru change management and change control systems and develop risk mitigation and contingency plans
• Documentation and change management of custom code.
• Software and hardware architectural design for the manufacturing and inspection equipment

Education/Experience:

Bachelor’s Degree required. One (1) year experience in operations development preferred. Degree in Computer Science or related field preferred. FDA regulated environment preferred

Skills:

Building and enhancing custom solutions using .Net/C#/Ruby. Web technologies such as HTML, CSS, JavaScript, SQL, Cloud Computing MS Azure, Google or AWS experience preferred

Knowledge:

Limited use and/or application of basic principles, theories, and concepts.  Limited knowledge of industry practices and standards.

Reasoning Ability:

Solves routine problems of limited scope and complexity following established policies and procedures.

Discretion/Latitude:

Work is closely supervised.  Follows specific, detailed instructions. 

Machine, Tools, and/or Equipment Skills:

PC servers, workstations and laptops.  Microsoft environment. Work with standard current computer applications, word processing, spreadsheets, enterprise applications such as ERP, MES, PLM and CRM.

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.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.  The area that this job is performed in is a general office or open cubicle/workstation environment.  The noise level in the work environment is usually moderate.

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.