Engineer Principal - Electrical - Product Development - Medical Devices

Engineer Principal
- Electrical
- Product Development
- Medical Devices

Arthrex is a global medical device company and a leader in new product development and medical education in orthopedics. The Engineer Principal
- Product Development will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance. The ideal candidate for this Principal Engineer role at Arthrex is a seasoned technical leader who bridges the gap between high-level design and clinical execution. Given the 12-year experience requirement, this person is not just a designer but a subject matter expert capable of steering entire product life cycles and mentoring junior staff.

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 a history design file for assigned projects, adhering to Arthrex design control procedures.
• Provides Regulatory department with 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 them on technical aspects of assigned products as needed.
• Determines necessity of testing and initiates testing of assigned products
• Reports on 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:

• Regularly contributes to the development of new concepts, techniques, and standards.
• Considered expert in field within the organization.

Reasoning Ability:

• Develop solutions to a variety of complex problems.
• May refer to established precedents and policies.

Discretion/Latitude:

• Work is performed under general direction. Participates in determining objectives of assignment. Plans schedules and arranges own activities in accomplishing objectives. Work is reviewed upon completion for adequacy in meeting objectives. May supervise the activities of lower-level personnel.

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. Pro/E and/or Solid Works 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.

Education/

Experience:

• 12 Years of experience Bachelor's degree (or equivalent experience) required preferably in Engineering (Mechanical, Biomedical, Electrical or Software Engineering) or Computer Science MS Preferred

Reasoning Ability:

• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.
• Mathematical Skills Ability to comprehend and apply mathematical principles to the degree required to perform the job based upon job requirements.
• Language and Communication
  
  Skills:
  
  Ability to comprehend and apply language skills to the…