Sr. Engineer II - Product Development - Arthroplasty

Arthrex GmbH; Naples (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Matching 401(k) Retirement Plan

Annual Bonus

Free Onsite Lunch

Tuition Reimbursement Program

Job summary

Arthrex GmbH in Naples, Florida is seeking a Sr. Engineer II to lead the full life cycle development of medical devices within Arthroplasty. The candidate should have a Bachelor's degree in Engineering and 8 years of relevant experience, with proficiency in FDA and ISO guidelines and 3D-CAD design software. Responsibilities include project management from initiation to execution and providing technical support across teams. The position offers comprehensive insurance, onsite medical clinics, and a wellness incentive program.

Qualifications

• 8 years of relevant work experience required.
• Strong understanding of FDA and ISO guidelines for development.
• Technical knowledge in development methodologies and design.

Responsibilities

• Designs components or functional systems and modifies existing designs.
• Leads multifunctional new product project teams through project phases.
• Provides technical support for projects as needed.

Skills

Knowledge of FDA and ISO guidelines for the development of medical devices

Proficiency in designing products using a 3D-CAD program (Creo/SolidWorks)

Manufacturing process knowledge

Project management skills

Working knowledge of anatomy from an orthopedic standpoint

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 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

• 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.
• 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.