Every day, Baxter touches the lives of millions of patients and providers worldwide who rely on our essential hospital and renal products and services. You’ll find Baxter’s products and therapies on nearly every floor, in almost every hospital worldwide, in clinics and in the home. Baxter’s employees are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care. Our commitment to our mission means we are there when patients and healthcare professionals need us, during the critical moments that matter most.
Provide technical leadership in Design Transfer activities for Device Engineering. Drive standardized execution of a Design Transfer process that is effective, efficient, and compliant in transferring Product Designs to Operations and Post Market Surveillance.
- 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.
- Leads the team to identify and implement continuous improvement in 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.
- Anticipates potential conflict situations for proactive solutions and manages conflict situations to result in win-win outcomes.
- Continuously interacts with all functions and levels of management ensuring effective communications across teams and stakeholders
- Motivates and successfully influences stakeholders and cross-functional team members within the project.
- Bachelor degree required (Mechanical, Electrical, or Manufacturing Engineering preferred)
- 10 years of product life cycle experience with demonstrated success leading projects in the medical products industry; 5 years of experience working with manufacturing engineering activities/issues; 5 years of project management experience
- Able to effectively manage and lead complex, multi-sited projects. Has led the transfer of several significant projects.
- Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
- Understanding of Good Manufacturing Practices, Good Laboratory or Clinical Practices.
- Advanced Manufacturing Systems experience preferred.
- Six Sigma Green belt or Black Belt (DFSS) certification, LEAN certification preferred
- Requires a high level of independence and ability to develop and influence others.
- Excellent verbal and written communication skills, strong interpersonal skills, and be persistent when the need arises
- Demonstrated peer-leadership, diplomatic and negotiating skills
- Experience working with virtual teams and across multiple design centers.
- Competent application of Vital Behaviors and Leadership Essentials.
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.
EEO is the Law
EEO is the law - Poster Supplement
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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.