Sr. Engineer II - Product Development - Arthroplasty

Arthrex; Naples (FL); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Matching

Job summary

Arthrex, Inc. is a global medical device company focused on advancing orthopedic care. We are seeking a Sr.

Engineer II to lead full life-cycle development of medical devices in Arthroplasty, coordinating with regulatory, manufacturing, and marketing teams. The role requires a Bachelor's in Engineering, 8 years of experience, and strong CAD skills (Creo/SolidWorks). Travel may be required; knowledge of FDA/ISO guidelines and implants is essential.

Qualifications

• Bachelor's degree in Engineering required.
• 8 years of relevant work experience required.
• Experience in designing and developing orthopedic implants and medical devices.
• Knowledge of FDA/ISO guidelines required.
• CAD design proficiency with Creo/SolidWorks essential.
• Strong project management and communication skills preferred.

Responsibilities

• Design components or systems and modify designs to improve products and manufacturing operations.
• Lead multifunctional project teams through feasibility, initiation, planning, execution and termination within time/budget.
• Maintain design history file in accordance with Arthrex procedures.
• Provide Regulatory department technical support for projects.
• Support Marketing/PM with technical information for training and marketing.
• Assist Manufacturing with processing improvements.
• Educate surgeons and distributors on technical aspects; travel to accounts.
• Determine budgets and timelines for assigned projects; report progress regularly.

Skills

Orthopedic implant design

FDA & ISO guidelines knowledge

CAD design proficiency (Creo/SW)

Manufacturing processes knowledge

Project management & communication

Anatomy knowledge (orthopedic)

Joint anatomy knowledge

Development methodologies & project实施

Orthopedic surgery principles & theory

Education

Bachelor's degree in Engineering

8 years of relevant work experience

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

• Design components or functional systems and modify existing designs to develop or improve products and facilitate manufacturing operations.
• Recommend alterations to development and design to improve quality of products and/or procedures.
• Determine budgets and timelines for assigned projects.
• Lead 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.
• Maintain design history file for assigned projects, adhering to Arthrex design control procedures.
• Provide Regulatory department technical support for assigned projects as needed.
• Support Marketing and Product Management with technical information to be used for training and marketing of assigned products.
• Support Manufacturing to provide processing improvements.
• Support surgeon and distributor customers by training and/or educating on technical aspects of assigned products as needed.
• Determine necessity of testing and initiate testing of assigned products.
• Report progress and status of assigned projects on a timely basis.
• Travel to attend trade shows and visit established and prospective accounts.
• International travel may be required.

Skills

• Experience designing and developing orthopedic implants required.
• Knowledge 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 principles, theories, and products preferred.

Knowledge

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

Education / Experience

• Bachelor's 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.

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.