Engineer - Mechanical - Medical Devices

Engineer I - Mechanical - Medical Devices

Title
:
Engineer I - Mechanical - Medical Devices

Salary Range:
Salary Minimum: [[salary

Min]]
Salary Maximum: [[salary

Max]]

The Engineer I – Mechanical will be responsible for full life cycle development of medical devices, which includes initiation, design, development, execution, and product maintenance.

Essential Duties and Responsibilities:

• Designs components or functional systems and modifies existing designs to develop or improve products as well as facilitate manufacturing operations.
• Recommends alterations to development and design to improve quality of products and/or procedures.
• Works with finance and extended team to determine budget for assigned projects.
• Works with project management and extended team to determine timeline for assigned projects.
• Primary mechanical resource on 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.
• Works with Systems Engineering to create and maintain 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.
• Works with extended team to ensure design considers the needs of internal stakeholders (Manufacturing, Service, Quality, Sourcing, etc.)
• Supports Manufacturing and Service process creation (assembly/disassembly/rework), ensuring processes maintain design intent.
• 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.
• Regularly attends surgical observations (live surgery, wet labs, and/or dry labs) to gather input from end users and identify opportunities for product improvement.
• May be required travel to attend trade shows and visit established accounts as well as prospective accounts. International travel may be required.

Knowledge:

• Limited use and/or application of basic principles, theories, and concepts. Limited knowledge of industry practices and standards.
• Solves routine problems of limited scope and complexity following established policies and procedures.

Reasoning/Ability:

• Solves routine problems of limited scope and complexity following established policies and procedures.
• Work is closely supervised. Follows specific, detailed instructions.

Skills:

• Knowledge of FDA and ISO guidelines for the development of medical devices preferred.
• Manufacturing process knowledge preferred.
• Project management and communication skills training preferred.
• Working knowledge of anatomy from an orthopedic standpoint preferred.
• Entry level skills in designing products using a 3D-CAD program required (Solid Works preferred).
• Working knowledge of latest ASME Y14.5 standards.
• Working knowledge of tolerance analysis (stack-up) methods.
• Working knowledge of one or more design simulation and/or analysis tool (FEA, CFD, optical ray tracing, etc.)
• Working knowledge of Design for Quality tools such as FTA, FMEA, HALT/HASS

Education/

Experience:

• BS Degree Mechanical 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 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.