Sr. Engineer I - Product Development - I&R

SHPE Houston; Naples (FL); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, Dental and Vision Insurance

Company-Provided Life Insurance

401(k) Retirement Plan

Annual Bonus

Tuition Reimbursement Program

Paid Time Off

Job summary

Arthrex, Inc. in Naples, FL, seeks a Sr. Engineer I (Mechanical) for Product Development to support the Fluid Management team. You will own full life cycle development of medical devices, from concept through design history file and production readiness.

The candidate should have 5 years of relevant experience and a Bachelor's degree in Mechanical or Electrical Engineering, plus proficiency with SolidWorks or Creo, and knowledge of DFMs and orthopedic product nuances. Travel may be required.

Qualifications

• 5 years of relevant work experience.
• Bachelor's degree in Mechanical or Electrical Engineering.
• Experience with fluid and vacuum system components preferred.

Responsibilities

• Designs components or functional systems and improves products.
• Manages budgets and timelines for assigned projects.
• Leads multifunctional project teams through feasibility, initiation, planning, execution and completion.
• Maintains design history file per design control procedures.
• Provides regulatory technical support for projects as needed.

Skills

3D CAD design

Project management

Manufacturing processes

FDA/ISO knowledge

Anatomy knowledge

Biomedical device dev

Education

Bachelor's degree in Mechanical or Electrical Engineering

Tools

SolidWorks

Creo

Job description

Requisition ID:

67338

Title:

Engineer, Sr. I (Mechanical) - Product Development - I&R

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.
• Electromechanical product development experience 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.

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.