Achieves desired product technical outcomes through the indirect management of R&D/Operations individuals and R&D/Operations teams(s) and the direct completion of complex Product Design Control, CAPA, Change Control (CC), Supplier Notification of Change projects within the boundaries of timing and budget.
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Based on significant technical expertise, reviews and approves complex product design changes [with PDOs or local technical staff (SMEs)] and provides technical product direction for the local manufacturing operations team.
Provides technical and design-leadership expertise on the Elastomerics product family. Serves as Product Design Owner (PDO) delegate initially, with development to PDO onsite.
Fosters an environment of rigor, completeness and compliance when participating on plant CAPA, CC or FCA investigations/assessments.
Responsible for technical and project management of a constantly changing initiative portfolio that are Operations, Quality Systems (QS), Process, Customer or Supply Chain-based.
Responsible for triage escalation to global R&D team members, and managing plant, R&D, and management stakeholder expectations with regard to timing and deliverables.
Accountable for the technical execution annually of plant/quality initiatives. Responsible for first response to external authorities on design/product specs/product requirements.
Serves as a champion of all product/design activities.
Essential Duties and Responsibilities
Technical Product/Process Expertise
Organizes and provides technical leadership for the QS elements (eg CAPA, CC), RBLCM and playbook utilization, TMV development and/or transfer, formulation development, process development, tech transfers.
Generates innovative technical solutions to complex product-related problems through the use of multiple disciplines and technical principles. Provides guidance for robust use of DMAIC and critical-thinking. Familiar with use of and improvement to playbooks. Creative use of innovative products/processes/methods.
Maintains current knowledge of relevant QS Regulations and other regulatory requirements related to product development, design and safety, and risk reduction to ensure compliance in all research, data collection and reporting activities.
Ensures yearly projects and goals are strategically aligned with MWER & QMR (with technical "Measures").
Project and People Management
As the Technical Lead on R&D plant projects, develops effective project milestones, and schedules and manage budgets, including capital. Employs project management tools to manage project schedules and budgets against milestones; reviews and applies best-demonstrated practices, team processes, and improves operational efficiency. Identifies and resolves issues that may jeopardize product release, project schedules or improve project time. Seeks regular input and feedback from customers and takes appropriate action.
Demonstrates leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc. Member of the Plant and Quality Leadership teams.
Defines and communicates strategic imperatives to project success, innovative technology and costs.
Ensures that personal and team objectives align with key plant programs (product initiatives, VIPs, strategic imperatives).
Leads cross-functional teams in defining, developing goals, and orchestrating team process for simple to very complex projects and programs. Approves team deliverables for project completion.
Selects, develops, and manages direct reports, as applicable. Provides guidance for team members in close collaboration with their direct supervisor. Ensures that the team achieves stated and agreed-upon goals.
Maintains direct involvement with R&D and management for triage/escalation issues. Recommends, implements, and manages projects through the appropriate SPO program structure and performance throughout all product project phases. Interacts through program updates and reviews with all levels of management.
Supports project evaluations and recommends changes, continuation, or termination as appropriate. Responsible for making appropriate risk based decisions when there is substantial product/process impact.
Relevant technical discipline, preferably an advanced degree in Medical Device or Materials Engineering, with a broad background in problem solving in Elastomerics Materials.
Design and implementation of technical studies and /or plans, especially as they relate to CAPA, CC or FCA assessments.
Strong leadership and project management to achieve results.
Strong quantitative and qualitative assessment skills and critical thinking skills in support of analyzing and solving complex problems through innovative thought and experience.
Skilled at presentations within the business/technical community.
Interpretation of results from a variety of scientific datasets.
Human relation skills for group leadership, individual leadership, and project management.
Demonstrated ability to lead technical projects through successful outcomes.
Ability to lead, manage and facilitate cross-function/division teams.
Must be self-motivated, resourceful, flexible. A self-starter is imperative.
Must have strong interpersonal and effective communication skills.
Must possess knowledge of related disciplines, especially manufacturing operations and quality systems.
Ability to design and implement projects/studies outside area of expertise.
Must have strategic leadership and proficient supervisory skills.
Technical writing proficiency.
Education and/or Experience.
B.S. in Engineering with at least 10 years on the job, M.S. with 8 years relevant experience, or PhD with 4 years relevant experience. Project management skills/experience required.
Must be available to train 2-4 months in Round Lake, IL USA with R&D Disposable Device Team on Baxter Elastomeric Products prior to starting role at job site (Irvine, CA).
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.
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