Systems Engineer, Sr II - Arthrex Digital Innovation

Arthrex•Pelican Bay, FL

About The Position

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 a Systems Engineer to join our Digital Innovation team. In this role, the successful candidate will lead cross-functional product development efforts through feasibility, planning, design, verification, and product launch activities, ensuring alignment with technical, regulatory, quality, and business objectives. This role will be responsible for developing system architectures, defining system-level requirements, integrating hardware and software components, managing product reliability initiatives, and ensuring compliance with global standards and medical device regulations. The Systems Engineer will collaborate closely with engineering, quality, regulatory, product management, manufacturing, and external development partners to deliver innovative, reliable, and compliant technology solutions that support Arthrex's strategic objectives. Strong technical leadership, analytical problem-solving, systems thinking, and project management skills, along with experience in medical device product development and a Bachelor's degree in Engineering are essential for this position. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Requirements

Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
Manufacturing process and inspection knowledge required.
Experience with project management methods
Strong technical communicator
Broad knowledge of medical device product development lifecycle from concept through production release.
Ability to lead complex, cross functional teams independently.
Leads strategic discussion that addresses both business and technical risks
Deep technical knowledge in development methodologies, design, and project implementation.
Experienced in the application of systems engineering to the medical device industry.
8 years of relevant work experience is required
Bachelor’s degree in Engineering is required

Nice To Haves

Historical perspective on orthopedic surgery principals, theories, and products preferred.
Master's Degree is preferred

Responsibilities

Leads multifunctional new product project teams, as assigned by Engineering Manager, through project technical feasibility analysis, initiation, planning, execution, and termination, adhering closely to project timeline and budget.
Develop system architecture documentation
Establish design inputs and/or system level requirements, ensuring compliance to Arthrex QMS and global standards and regulatory requirements
Decompose product requirements into discipline specific product specifications, collaborating with other engineering functions.
Designs components or functional systems and modifies existing designs to develop or improve products and facilitate manufacturing operations.
Recommends alterations to development and design to improve quality of products and/or procedures.
Develop, track, and monitor functional systems needs and reliability throughout a product’s life cycle, making recommendations on corrective actions and/or potential enhancements.
Perform and develop methods to objectively quantify system performance/function.
Manage tradeoffs between performance, cost, schedule.
Manage external development partners and their deliverables throughout the product development lifecycle.
Integrate all components and subsystems into a functioning system
Review design verification plan and procedures
Provides Regulatory department technical support for assigned projects as needed.
Develop and manage product compliance initiatives to relevant standards governing medical electrical equipment (IEC60601).
Work with notified bodies (e.g. UL, TUV) to demonstrate product compliance to IEC60601
Coordinate testing to be performed to ensure compliance to all ISO, IEC, and regulatory standards required for a given product or assignment.
Manage completion of Design Control Documentation and maintain design history file for assigned projects, adhering to Arthrex design control procedures.
Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
Support the execution of engineering changes, lifecycle changes, and/or document changes prior to release.
Review product complaints and perform root cause failure analysis
Identify and pursue novel technology to support future strategic opportunities.
Support Quality System Audits conducted by external agencies, such as FDA, Notified Body and/or Regulatory Agency audits.
Contribute to efficient and effective program management
Ensure alignment of internal and external customers.
Focus on Reliability: A significant portion of this role may be involved in the following tasks concerning reliability testing and characterization with both hardware and software: Root cause failure analysis, Design of Experiments (DOE) and cycle testing, Product Complaints and field failures analysis, Test fixture design and support, Working with vendors and consultants on rapid prototyping and fixture design, Reliability analytics, Bug discovery, Managing a reliability lab space, Drafting and executing reliability test protocols, Creating design and process change proposals.