Engineer, Sr. II - Product Development - Arthroplasty

Arthrex GmbH; Naples (FL); On-site; USD 100,000 - 160,000; Full time

Benefits offered by this job

Medical, dental & vision insurance

Matching 401(k) retirement plan

Annual bonus

Wellness program

Paid time off

Tuition reimbursement

Job summary

Arthrex, Inc. is seeking a Sr. Engineer II to support multiple projects within Arthroplasty.

The role involves full life cycle development of medical devices, from initiation through maintenance, with emphasis on adhering to FDA and ISO guidelines and applying design controls. The candidate should have strong knowledge of orthopedic anatomy, CAD design skills, and project leadership experience. Responsibilities include leading cross functional teams, managing budgets and timelines, and

Qualifications

• Bachelor's degree in Engineering is required.
• 8 years of relevant work experience required.
• Experience designing orthopedic implants preferred.
• Knowledge of FDA/ISO guidelines for medical device development required.
• 3D-CAD design proficiency with Creo/SolidWorks required.

Responsibilities

• Design components or systems and modify existing designs to improve products.
• Lead multifunctional new product project teams through feasibility, planning, execution, and closure.
• Maintain design history files per Arthrex procedures.
• Provide Regulatory and cross-functional support as needed.
• Train and support marketing, manufacturing, and customers on technical aspects.
• Travel to trade shows and customer sites as required.

Skills

Project management

Communication skills

Anatomy knowledge

Orthopedic concepts

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:

• 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.
• 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.
• 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.