Job Description :
Baxter International Inc. provides a broad portfolio of essential renal and hospital products, including home, acute and in-center dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; biosurgery products and anesthetics; and pharmacy automation, software and services. The company's global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter's employees worldwide are building upon the company's rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Primary Function / Primary Goals / Objectives:
Provide technical leadership in Design Transfer activities for Device Engineering. Establish a Design Transfer process and function that is effective, efficient, and compliant in transferring Product Designs to Operations and Post Market Surveillance, and to maximize the benefits of standardized execution.
- Responsible for leading the activities associated with the Design Transfer of one or more new products from R&D into Operations and Post Market Surveillance.
- Drive completion of commercialization activities to achieve the launch of new products.
- Independently manages the transfer of complex large projects, or several smaller projects of low or moderate complexity.
- Expedite, manage, and coordinate interrelated Design Transfer activities across functions, within the constraints of human and financial resources and changing priorities.
- Participate in identifying and planning tasks, activities, and resourcing needs related to Design Transfer.
- Provides leadership and subject matter expertise to product development teams to ensure product design is manufactureable, serviceable, and set up for effective Post Market Surveillance.
- Assesses and improves design transfer effectiveness.
- Leads Design Transfer Planning and coordination with Risk Based Lifecycle Management activities.
- Collaborates with Manufacturing and Service in the development of Process FMEAs and Control plans related to Essential Design Outputs.
- Creates and approves Design History File deliverables associated with Design transfer.
- Participates in change control process to assess, approve, and implement changes to DMR documents during product development.
- Leads defining and transferring effective diagnostic and troubleshooting strategies from R&D to Service, and ensuring Service record coding enables effective monitoring in Post Market phases.
- Provides leadership in Product Design Cost stewardship
- Collaborates with Supply Chain and Supplier Quality and interacts with third party suppliers of materials required for the product.
- Recognizes strategy, evaluates risks, recommends actions and develops contingencies to address various scenarios. Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.
Qualifications : Education:
- Motivates and successfully influences stakeholders and cross-functional team members within the project
- Bachelor degree in Mechanical, Electrical, or Manufacturing Engineering and 8+ years of experience
- Minimum of 5 years of relevant experience in medical device manufacturing industry.
- Able to effectively manage and lead complex projects. Has led the transfer of at least one significant project.
- Advanced Manufacturing Systems experience preferred.
- Six Sigma Green belt or Black Belt (DFSS) certification, LEAN certification preferred
- Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control
- Requires a high level of independence and excellent interpersonal and communication skills.
- Prepare and present written and oral reports and other presentations to internal and external audiences as required.
#LI-AS1Equal 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.
EEO is the Law
EEO is the law GINA Supplement Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an email to Corporate_Staffing_Deerfield@baxter.com or call 877-229-4748 (877-BaxHR4U) and let us know the nature of your request along with your contact information.
A little about us:
Our employees are connected by an enduring commitment to save and sustain lives. This higher purpose binds us in doing work that matters.