Senior Mechanical Engineer, Medical Device Product Dev

Arthrex GmbH; Naples, Northern (FL, KY); Hybrid; USD 100,000 - 140,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Annual Bonus

Matching 401(k) Retirement Plan

Tuition Reimbursement Program

Paid Parental Leave

Job summary

Arthrex, Inc. is actively seeking a Sr.

Engineer I (Mechanical) – Product Development to support the Fluid Management team in Naples, FL. You will oversee full life cycle development of medical devices, including initiation, design, development, execution, and maintenance, while ensuring compliance with design controls.

Qualifications

• Bachelor's degree in Mechanical or Electrical Engineering is required.
• 5 years of relevant work experience is required.
• Experience with FDA/ISO guidelines for medical devices is required.

Responsibilities

• Lead cross-functional NPD teams through feasibility, initiation, planning, execution, and termination.
• Maintain design history file per Arthrex procedures and design controls.
• Provide regulatory and technical support for projects as needed.
• Support Manufacturing with process improvements and design for manufacturability.
• Assist Marketing/PM with technical information for product training and materials.
• Travel to trade shows and accounts as required, including international travel.

Skills

FDA/ISO compliance

DFM principles

3D CAD (SolidWorks/Creo)

Project management

Fluid/vacuum components design

Orthopedic anatomy knowledge

Engineering principles

Education

Bachelor's degree in Mechanical or Electrical Engineering

Tools

SolidWorks

Creo

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 (Mechanical) – Product Development to support the Fluid Management team. 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 required.
• Experience with Design for Manufacturability (DFM) principles, in depth knowledge of materials, manufacturing processes and design optimization is preferred.
• Project management and communication skills training preferred.
• Experience in designing and selecting the fluid and vacuum system components such as seals, valves, piping is 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. SolidWorks and/or Creo experience preferable.
• Technical knowledge in development methodologies, design, and project implementation.
• Knowledge of orthopedic surgery principles, theories, and products preferred.

Education/ Experience:

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