The Renal Lead System Integrator (LSI) team is a part of the R&D organization that supports the Renal Care business unit. Within the team we provide project management activities in all product phases, innovation initiatives, new product development and improvement programs for existing therapy systems. This collaborative role gives you the direct opportunity to define solutions to new products and services to patients and continue Baxter s mission to save and sustain lives.
Baxter is a global company with R&D sites at multiple locations in the world; competences and capabilities are spread over the different R&D sites, and you will commonly collaborate with colleagues across several of these R&D sites. Work assignments within the team are highly variable and we can promise you a work environment with exciting project management challenges and variability in your day-to-day activities.
Lead System Integrator co-ordinates/leads R&D team within a Project or Program with her/his Project Management and Technical Leadership skills.
Essential Duties and Responsibilities:
- Lead research and development (R&D) project management work and research for medical devices and regulated healthcare products
- Owner of R&D program schedule creation, tracking, and execution. Responsible for delivering an integrated product with detailed plans from primary iteration to successful system verification completion
- Participates as a member of cross functional teams and/or integrates cross functional inputs into project delivery
- Accountable for project execution and proactive risk management. Effectively tracks project status, risks and external spend.
- Demonstrates understanding of and adherence to FDA, ISO and IEC design control procedures, regulations, and standards
- Prepares project reports, analyses and delivers presentations to R&D leadership on a weekly basis
- Leads scheduled meetings in R&D, develops and manages agenda, creates minutes, and follows up action items throughout the integration steps
- Establish project communication channel. E.g., Teams group, Status meeting, Escalation matrix, etc.
- Facilitate/organize project design reviews and change control meetings
- Release POs and approve corresponding invoices for the R&D tasks executed by external vendors (e.g., external labs, translation agencies, etc.)
Qualifications:
- Experience in project management principles and methodologies
- Strong interpersonal and communication skills in written and verbal form
- Demonstrated ability to draw conclusions and make recommendations based on technical inputs from multiple and varied functions (Marketing, Quality, Regulatory, etc.).
- Ability to provide technical leadership for medical device projects with substantial complexity and scope.
- Ability to decompose complex problems into actionable task lists
- Understanding of design requirements for development, validation, and verification of medical products
Education and Experience:
- Bachelors degree in Engineering or equivalent field
- 3+ years of R&D experience; experience in medical device industry preferred