Sr. Engineer I - Product Development - Suture Development

Arthrex•Pelican Bay, FL

About The Position

Arthrex is seeking a Sr. Engineer I - Product Development to join its Suture Development team. The role supports development and optimization of suture-based products by determining material, yarn, sizing, and strength requirements; partnering with manufacturing to produce prototypes; and driving design improvements and maintenance projects. The engineer develops and executes test methods and protocols, analyzes data, manages design documentation and change requests in Windchill, and collaborates with Quality, Regulatory, Product Development, and other cross-functional teams to support suture solutions across multiple product portfolios. The position designs and modifies components or functional systems to improve products and facilitate manufacturing, recommends changes to improve product or procedural quality, and determines budgets and timelines for assigned projects. As assigned by the Engineering Manager, the engineer leads multifunctional new-product project teams through feasibility analysis, initiation, planning, execution, and termination while following project timelines and budgets. The role maintains design history files according to Arthrex design-control procedures, provides technical support to Regulatory, Marketing, Product Management, and Manufacturing, and may train or educate surgeon and distributor customers on product technical aspects. The engineer determines when product testing is needed, initiates testing, and reports project progress and status in a timely manner. Travel to trade shows and customer accounts, including international travel, may be required.

Requirements

Bachelor's degree in engineering.
Five years of relevant work experience, excluding academic coursework and internships.
Knowledge of FDA and ISO guidelines for medical-device development.
Proficiency in designing products using a 3D-CAD program.
Complete understanding and application of relevant principles, concepts, practices, and standards.
Full knowledge of industry practices.
Technical knowledge of development methodologies, design, and project implementation.

Nice To Haves

Manufacturing-process knowledge.
Training in project management and communication skills.
Working knowledge of anatomy from an orthopedic standpoint.
Working knowledge of joint anatomy.
Pro/ENGINEER (Pro/E) and/or SolidWorks experience.
Knowledge of orthopedic surgery principles, theories, and products.
Historical perspective on orthopedic surgery principles, theories, and products.
Experience with textile development, including polymer science applications and manufacturing processes such as braiding, weaving, and knitting.

Responsibilities

Design components or functional systems and modify existing designs to develop or improve products and facilitate manufacturing operations.
Recommend development and design alterations to improve product or procedural quality.
Determine budgets and timelines for assigned projects.
Lead assigned multifunctional new-product project teams through technical feasibility analysis, initiation, planning, execution, and termination, while adhering to project timelines and budgets.
Maintain design history files for assigned projects in accordance with Arthrex design-control procedures.
Provide technical support to the Regulatory department for assigned projects as needed.
Support Marketing and Product Management with technical information for training and marketing assigned products.
Support Manufacturing by providing processing improvements.
Train or educate surgeon and distributor customers on technical aspects of assigned products as needed.
Determine the need for product testing and initiate testing.
Report assigned project progress and status in a timely manner.
Develop and optimize suture-based products by determining material, yarn, sizing, and strength requirements, partnering with manufacturing to produce prototypes, and driving design improvements and maintenance projects.
Develop and execute test methods and protocols, analyze data, and manage design documentation and change requests within Windchill.
Collaborate with cross-functional teams to support suture solutions across multiple product portfolios.

Benefits

Medical, dental, and vision insurance.
Company-provided life insurance.
Voluntary life insurance.
Flexible Spending Account (FSA).
Supplemental insurance plans (accident, cancer, hospital, and 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).