Systems Engineer, Sr II - Arthrex Digital Innovation

Arthrex, Inc. is a global medical device company and a leader in new product development and medical education in orthopedics. We are actively searching for a Systems Engineer to join our Digital Innovation team.

About the 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 involves 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.

Responsibilities

• Leads multifunctional new product project teams 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 with Arthrex QMS and global standards and regulatory requirements.
• Decompose product requirements into discipline-specific product specifications, collaborating with other engineering functions.
• Design components or functional systems and modify existing designs to develop or improve products and facilitate manufacturing operations.
• Recommend 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, and 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.
• Provide 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 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.
• Support 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.
• 10-15% travel (domestic and international) may be required.

Focus on Reliability

A significant portion of this role may involve 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

Requirements

• Knowledgeable of FDA and ISO guidelines for the development of medical devices.
• Manufacturing process and inspection knowledge.
• 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 discussions that address both business and technical risks.
• Deep technical knowledge in development methodologies, design, and project implementation.
• Historical perspective on orthopedic surgery principles, theories, and products preferred.
• Experienced in the application of systems engineering to the medical device industry.

Qualifications

• 8 years of relevant work experience is required.
• Bachelor’s degree in Engineering is required.
• Master’s Degree is preferred.

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 Onsite Lunch
• Tuition Reimbursement Program
• Trip of a Lifetime
• Paid Parental Leave
• Paid Time Off
• Volunteer PTO
• Employee Assistance Provider (EAP)