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Principal Engineer (R&D - Product Development)

Req #: 170008BL_en
Location: St Paul, MN US
Job Category: Research and Development
Date Posted: 11/15/2017 3:53:22 PM
Baxter International

You will be responsible for developing creative solutions to challenging issues associated with the design, development, and sustaining engineering for our Microsurgery and Soft Tissue business.  The successful candidate will possess solid technical abilities, project management abilities, and leadership skills, bringing excitement and energy for product development, a passion for their work, and the impact it has on meeting the needs of patients.

 

·       Perform in the role of Lead System Designer, manage technical execution of multiple new product development programs

  • Lead and drive the R&D resources assigned to projects to meet or exceed project targets in schedule, budget, and quality
  • Molding, over-molding, and micro-molding knowledge and experience preferred
  • Lead Technical Reviews and be the lead R&D voice in Design Reviews
  • Partner closely with the Science Lead and Product Design Owner
  • Primary point of contact for the project technical deliverables and interface with cross-functional teams; Subject Matter Experts, Functional Managers, Project Management, and Senior Management
  • Responsible for guiding cross-functional teams through device design control processes with responsibility for translating project objectives into execution and specification levels
  • Expected to provide input to risk process, perform Engineering Investigations (EI), and be a voice of knowledge for process development, problem solving, issue resolution and risk mitigation
  • Directs teams in the determination of acceptability of correction, as assigned - corrective and preventative actions by considering impacts on performance, safety, costs, fielded product, manufacturing, and other factors
  • Anticipates potential conflict situations and proactively proposes solutions and resolves conflict situations, project bottlenecks as they arise, negotiating effectively with project teams
  • Prepares project reports, analyses and delivers presentations to leadership as requested
  • Provide bi-weekly status to manager and monthly updates to R&D team as needed
  • Manage and nurture partnerships with 3rd party developers and work with external IP holders in turning ideas into manufacturable and marketable products

·         Ability to work within multiple quality systems between vendors and Baxter with confidence and provide stability in the translations between organizations

·         Independently plan, schedule and lead R&D team in detailed phases of the engineering work in a project

  • Coaches team members to ensure process adherence, technical design and delivery, utilizing best design and development practices and project management skills
  • Facilitates communication within assigned resources for execution tasks, owns and follows-up on all assigned deliverables
  • Provides feedback to functional department heads during strategic planning and the performance management process
  • Actively identifies and manage risks and issues through problem avoidance, contingency plans and proper escalation
  • Demonstrated success leading root cause analyses and implementing corrective actions (RCCA/CAPA)
  • Knowledge and experience in test method development and validation

·     Ability to exercise independent judgment and draw conclusions based on available information

·     Ability to influence management on proposed courses of action with minimal assistance using both written and verbal methods

 

Requirements

·         B.S. degree in Engineering and 8-10 years of experience, M.S. with 8+ year’s relevant experience, Chemical Engineer is a plus

·         Medical device experience preferred - prior experience in soft tissue process development a strong plus

·         Must have experience or advanced training and demonstrate proficiency with CAD, TQM, statistical methods, problem analysis and resolution, materials science, and design of experiments

·         Completely proficient in relevant product and process development processes

·         Recognized as a technical expert by peers and management

·         Extensive cross-functional team experience, including technical and non-technical work

·         Ability to organize and present technical and project management overviews without assistance

·         Demonstrated success in delivering results on several technical challenges

·         Demonstrated strong process optimization and analytical skills -

·         Proven ability to create results within budget, timeline, and deliverables

·         Self-motivated with good interpersonal skills, must be able to simplify the complex and speak to difference audiences

Understanding of and adherence to FDA, ISO and IEC design control procedures, regulations and standards

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