Displays standard engineering principles to develop creative solutions to challenging issues associated with the design, development, and sustaining engineering for Baxter’s Advanced Surgery business.
Essential Duties and Responsibilities:
- Achieves desired technical outcomes through the indirect management of individuals and teams(s) and the direct completion of complex Design Control, CAPA, CC projects or programs within the boundaries of timing and budget.
- Responsible for technical oversight of a constantly changing portfolio that impact R&D, Operations, Quality Systems (QS), Process, Customer or Supply Chain.
- Based on significant technical expertise, reviews and approves complex design changes (with PDOs) or local technical staff (SMEs) and provides technical product direction for the project team.
- Fosters an environment of rigor, completeness and compliance when participating on plant CAPA, CC or FCA investigations/assessments.
- Responsible for triage escalation to stakeholders of product risk and/or issues.
- Embraces accountability for critical decisions as a technical subject matter expert within a cross-functional team to drive product development deliverables, such as formulation development, process development, or tech transfers.
- Demonstrates understanding of and adherence to FDA, ISO, and IEC design control procedures and standards.
Technical Product/Process Expertise
- Creates design concepts and research methodologies that best meet current and future customer & business needs for a product or process domain area.
- Uses critical thinking and teamwork to contribute to the resolution of competing constraints.
- Create and maintain technical documents found in a DHF, such as verification/validation reports, technical drawings, and specifications.
- Develop and execute study plans and reports.
- Maintains detailed design documentation through all phases of product development.
- Manages phase gate and technical design reviews and identifies critical project risks.
- Demonstrates good business judgment in balancing budget, profitability and vendor relationships.
- Provides technical leadership to project teams working closely with the Project Manager, Quality, Manufacturing Engineering, and key technical core team members, guiding them in terms of problem resolution, process clarification, referrals to appropriate experts, etc.
- Defines and communicates strategic imperatives for innovative technology success and cost savings.
- Defend products to external agencies and corporate evaluations/audits.
- B.S. in engineering discipline (preferably Bioengineering/Biomedical/Mechanical Engineering) M.S preferred, with at least 5-8 years professional experience in a Medical Device/Pharmaceutical R&D role.
- Experience in creating/managing design documentation
- Skilled at written and verbal presentations within the business/technical community.
- Demonstrated ability to lead technical projects through successful outcomes.
- Must be self-motivated, resourceful, flexible. A self-starter is imperative.
- Preferred experience with CAD, TQM, statistical methods, problem analysis and resolution, materials science, and design of experiments.