Engineer, Sr. II - Product Development - Arthroplasty

Miami Neuroscience Institute Baptist Health South Florida; Naples (FL); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Paid Time Off

Tuition Reimbursement

Job summary

Arthrex, Inc. seeks a Sr. Engineer II to drive full life cycle development of Arthroplasty medical devices.

You’ll design components, ensure FDA/ISO compliance, and lead cross-functional teams from concept through launch. Strong 3D-CAD skills (Creo/SolidWorks) and orthopedic anatomy knowledge are essential. You will collaborate with Regulatory, Marketing, and Manufacturing, and may travel for trade shows and customer visits.

Qualifications

• Bachelor's degree in Engineering required.
• 8 years of relevant work experience required.
• Experience designing and developing orthopedic implants.
• Knowledge of FDA and ISO guidelines for medical devices.

Responsibilities

• Design components or systems and modify existing designs to improve products and manufacturing.
• Lead multifunctional product development teams, managing feasibility, initiation, planning, execution and budget.
• Maintain design history and support regulatory activities as needed.
• Support Marketing/PM with technical information for training and product promotion.
• Travel to trade shows and accounts as required.

Skills

Orthopedic implant design

FDA/ISO guidelines

Project management

3D-CAD design

Anatomy knowledge

Orthopedic principles

Manufacturing processes

Communication skills

Travel readiness

Education

Bachelor's degree in Engineering

8 years of relevant work experience

Tools

Creo

SolidWorks

Job description

Engineer, Sr. II - Product Development - Arthroplasty

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 II 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. The successful candidate would have a strong understanding of FDA and ISO guidelines for the development of medical devices. Additional preferred qualifications include knowledge of manufacturing processes, training in project management and communication skills, and a working knowledge of anatomy from an orthopedic standpoint, including joint anatomy. Proficiency in designing products using a 3D-CAD program is essential. The candidate should also possess technical expertise in development methodologies, design, and project implementation, along with familiarity with orthopedic surgery principles, theories, and products. 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.

Skills:

• Experience designing and developing orthopedic implants required.
• 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. 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.

Knowledge:

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

Education/ Experience:

• Bachelors degree in Engineering required.
• 8 years of relevant work experience required.

Incidental Duties:

• The above statements describe the general nature and level of work being performed in this job. They are not intended to be an exhaustive list of all duties, and indeed additional responsibilities may be assigned, as required, by management.

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.