Sr. Engineer I - Product Development - Arthroplasty

NBSTSA; Naples, Northern (FL, KY); Hybrid; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Tuition Reimbursement Program

Free Onsite Medical Clinics

Job summary

Arthrex, Inc. seeks a Sr. Engineer I - Product Development to drive full life cycle development of orthopedic medical devices. You will design components, lead cross-functional teams, and maintain design history files in line with design control procedures.

The role supports regulatory and marketing with technical input, trains surgeons and distributors, and may require travel to trade shows and accounts, including international travel.

Qualifications

• Bachelor's degree in Engineering required with 5 years of relevant work experience.
• Experience developing medical devices and adherence to design controls.
• Knowledge of regulatory guidelines (FDA/ISO) is preferred.

Responsibilities

• Design components or systems and modify existing designs to improve products.
• Lead multifunctional project teams through feasibility, initiation, and execution.
• Maintain design history file per design control procedures.
• Provide regulatory and cross-functional support for projects as needed.
• Train and educate customers, surgeons, and distributors on products.
• Travel to trade shows and accounts; international travel may be required.

Skills

FDA/ISO knowledge

Project management

Orthopedic anatomy

3D CAD design

Product development

QMS experience

Education

Bachelor's degree in Engineering

Tools

Creo

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 support various projects within Arthroplasty. This individual will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. 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 preferred.
• 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. Creo and/or 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.
• QMS experience preferred.
• Arthroplasty experience preferred.

Education/ Experience

• 5 years of relevant work experience excluding academic coursework or internships required.
• Bachelor's degree in Engineering required.

Arthrex 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)

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.