Sr Engineer I - Design Transfer - Arthroscopy

Arthrex - Naples, FL

Full-time - Mid Level

Naples, FL

Miscellaneous Manufacturing

About the position

The Sr. Engineer I - Design Transfer - Arthroscopy at Arthrex, Inc. is responsible for supporting new product development design transfer activities, ensuring compliance with quality management systems (QMS) and regulatory requirements. This role involves facilitating the transfer of product design specifications to manufacturing, improving manufacturability, and coordinating with various teams to ensure successful product launches.

Responsibilities

• Fully understand external regulatory and internal QMS requirements for Design Transfer.
• Review product specifications prior to finalization and recommend alterations to improve cost and manufacturability.
• Facilitate effective transfer of product design specifications from New Product Development to manufacturing.
• Work with Product Development Engineering to identify design transfer issues and risks.
• Establish plans for risk mitigation related to design transfer.
• Interact with manufacturing and external suppliers for accurate transfer of design specifications.
• Coordinate procurement of production equivalent product for design verification and validation activities.
• Determine and adhere to budgets and timelines for assigned projects.
• Provide required Design Transfer documentation for the Design History File.
• Support manufacturing and suppliers during scale-up of manufacturing and inspection activities.
• Determine necessary inspection criteria for verification of critical dimensions and functions.
• Report progress and status of assigned projects on a timely basis.

Requirements

• 5 years of relevant experience in engineering or related field.
• BS or MS Degree in Engineering (Manufacturing, Mechanical, Industrial, or Biomedical preferred).
• Knowledge of FDA and ISO guidelines for medical device development.
• Manufacturing process knowledge is required.
• Project management and communication skills training is required.
• Proficiency in 3D-CAD programs, preferably Creo or SolidWorks.
• Technical knowledge in development methodologies, design, and project implementation.

Nice-to-haves

• Historical perspective on orthopedic surgery principles, theories, and products.

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)