Design Validation Manager,
Baxter International Inc. - Round Lake, Illinois, United States, 60073
Work at Baxter International Inc.
Overview
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Overview
What You'll be doing
Conduct user needs research and collaborate with commercial teams to identify user needs and requirements for the various Infusion products. Develop and validate use cases and clinical infusion sequences for Infusion Pumps, Infusion Access Devices, and Infusion Elastomeric Pumps to support user needs. Collaborate with design teams to ensure user needs are captured and incorporated into system requirements for all Infusion products. Lead design validation activities, including study design, sample size justifications, vendor management, and recruitment of participants for validation and research purposes for all Infusion products. Ensure all design validation activities are conducted in accordance with relevant regulations and standards, and industry best practices. Collaborate with cross-functional teams to ensure seamless integration of user needs into the overall product development process for all Infusion products. Provide expert guidance and support to cross-functional teams as needed to ensure successful execution of design validation activities for all Infusion products. Select, develop and retain team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance.
What You’ll Bring Bachelor's degree in Engineering, Life Sciences, or a related field. Advanced degree preferred. Minimum of 8 years of experience in design validation, user needs research, and product development. Medical device and infusion system experience preferred. Strong understanding of relevant regulations and standards, including FDA and ISO for all Infusion products. Excellent analytical, problem-solving, and communication skills. Strong collaborative and leadership skills, with the ability to work effectively with cross-functional teams. Ability to travel up to 20% of the time as needed. Equal Employment Opportunity Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
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