Design Control Principal Engineer Medical Devices
Round Lake, IL
Req ID 51444BR
Business Title
Design Control Principal Engineer - Medical Devices
Business
Global Quality
Sub-Business
Global Compliance
Country
US
State/Province
Illinois
Location of Position
Round Lake, IL
Shift_
1st
Job Description
Summary:
Design Assurance is an entity within Corporate Quality with the role of owning, training, and coaching development teams on the medical device development process using design control regulations and engineering best practices as a guide. The Design Control Engineer uses standard medical device engineering principles to resolve difficult problems from conception to final design with team input. This position plans, schedules and leads project assignments in the evaluation, selection and adaptation of various engineering techniques, procedures, and criteria with minimal guidance.
Essential Duties and Responsibilities:
•With minimal guidance, schedule and coach a team through the planning and execution of a smaller project or defined piece of a larger project
•Coach development teams on subjects of the medical device product development process (dPDP), design for six sigma (DFSS) and metrics gathering
•Construct detailed, accurate project schedules, interface with development groups and technical support groups within different functions (engineering, regulatory, technical service, etc) and different product categories (renal, fluid systems, etc)
•Devise new approaches to complex problems such as design history file remediation through adaptations and modifications of standard technical principles
•Support development and maintenance of corporate quality procedures in the area of design control
•Independently assess development and design change program status in accordance with regulations and Baxter procedures
•Supervise and coordinate the work assigned to engineers and/or technicians
Job Requirements
Qualifications:
• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods
• Effectively operate in and may facilitate cross-functional teams with guidance
• Must be able to provide solutions that reflect understanding business objectives and cost implications
• Familiar with FDA and international medical device regulations
• Familiar with the risk management process Education and Experience:
• Bachelors Degree in Engineering and 5+ years of related experience Preferred Qualifications:
•Bachelors Degree in Electrical Engineering, Mechanical Engineering, Chemical Engineering, or Software Engineering
•Medical device design experience
•Internal and / or supplier auditing experience within a medical device company
•Working knowledge of FDA and international medical device regulations
•Familiar with the risk management process
Doing Work that Matters
Baxter provides its employees with comprehensive compensation and benefits. To view additional opportunities at Baxter and to learn more about the company, please visit our Web site at company website. EOE M/F/D/V.
