Sr. Engineer I - Product Development - Suture Development

Arthrex, Inc.; Naples (FL); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Medical, Dental & Vision Insurance

Company-Provided Life Insurance

401(k) Matching

Job summary

Arthrex, Inc. in Naples, FL, seeks a Sr. Engineer I – Product Development to advance suture-based products. You will determine material, yarn, sizing and strength requirements, and partner with manufacturing to develop prototypes.

You will create and execute test protocols, analyze data, and manage design documentation in Windchill while working with Quality, Regulatory and Product Development to support multiple product portfolios. Travel may be required.

Qualifications

• 5 years of relevant work experience.
• Experience with textile development including polymer science applications.
• Familiarity with braiding, weaving, and knitting manufacturing processes.
• Knowledge of FDA and ISO guidelines for medical devices.
• Proficiency in designing products using 3D-CAD (SolidWorks preferred).
• Knowledge of orthopedic surgery principles, theories and products.

Responsibilities

• Design components or systems and modify existing designs to improve products and manufacturing.
• Lead multifunctional new product project teams and manage scope, timeline, and budget.
• Maintain design history files and conform to Arthrex design control procedures.
• Provide Regulatory and cross-functional technical support as needed.
• Support Marketing and Product Management with technical information for training and marketing.
• Collaborate with Manufacturing to implement processing improvements.
• Train surgeons and distributors on technical aspects of products.

Skills

3D CAD design

SolidWorks

Project management

Regulatory knowledge

Orthopedic anatomy

Tools

SolidWorks

Job description

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 Sr. Engineer I – Product Development to join the Suture Development team. The successful candidate will support the 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. This role will be responsible for developing and executing test methods and protocols, analyzing data, managing design documentation and change requests within Windchill, and collaborating closely with cross-functional teams including Quality, Regulatory, and Product Development to support suture solutions across multiple product portfolios. Join our talented team at a global medical device company focused on Helping Surgeons Treat Their Patients Better™.

Essential Duties and Responsibilities:

• 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.
• Determines budgets and timelines for assigned projects.
• 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.
• Maintains design history file for assigned projects, adhering to Arthrex design control procedures.
• Provides Regulatory department technical support for assigned projects as needed.
• Supports Marketing and Product Management with technical information to be used for training and marketing of assigned products.
• Supports Manufacturing to provide processing improvements.
• Supports surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
• Determines necessity of testing and initiates testing of assigned products
• Reports progress and status of assigned projects on a timely basis.
• May be required travel to attend trade shows and visit established accounts as well as prospective accounts.
• International travel may be required.

Knowledge:

• Complete understanding and application of principles, concepts, practices, and standards.
• Full knowledge of industry practices.

Skills:

• Knowledgeable of FDA and ISO guidelines for the development of medical devices required.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of anatomy from an orthopedic standpoint preferred.
• Working knowledge of joint anatomy preferred.
• Proficiency in designing products using a 3D-CAD program. SolidWorks experience preferable.
• Technical knowledge in development methodologies, design, and project implementation.
• Knowledge of orthopedic surgery principles, theories, and products preferred.
• Historical perspective on orthopedic surgery principals, theories, and products preferred.

Education/Experience:

• 5 years of relevant work experience excluding academic coursework or internships required.
• Experience with textile development, including polymer science applications and manufacturing processes such as braiding, weaving, and knitting preferred.
• 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 Time Off
• Employee Assistance Provider (EAP)

All qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other status protected by law.