Job Description

Job Description:
You will lead the development of systems engineering solutions for multi-device systems within the medication delivery portfolio. The successful candidate will possess strong technical capabilities, provide leadership and mentorship within an R&D team, and demonstrate passion for their work and the impact it has on saving and sustaining the lives of patients.

•Defines system requirements and specifications based on customer or user requirements.
• Ensures system requirements are properly decomposed to subsystems and that all interfaces are captured appropriately.
• Contributes to development and documentation of system architectures.
• Drives risk management activities including Failure Mode Effects and Analysis (FMEA) and Safety Assurance Case (SAC) to ensure safety and effectiveness of designs.
• Ensures designs meet compliance objectives related to medical devices (such as IEC 60601) through proper design, test, and reporting of results.
• Defines appropriate test and verification methods to verify designs meet their performance requirements and assesses results for application, validity, and conformance to specifications.
• Leads the troubleshooting and problem solving efforts related to system level issues to identify root cause and recommend design solutions.
• Resolves competing constraints between interrelated functions (engineering, manufacturing, regulatory, marketing, etc.) required to deliver the product to market.
• Develops and maintains an effective and corroborative working relationship with internal and external development partners.
• time and resources to meet committed schedule milestones.

Qualifications
• Bachelor’s degree in engineering with at least five years related experience.
• A demonstrated track record in electro-mechanical system development and verification.
• Strong organization and communication skills, with the ability to interface with both technical and non-technical personnel throughout the organization.
• Familiarity with risk management processes and designing to compliance standards is preferred.
• Familiarity with requirements, test, configuration, and issue management tools such as DOORS, HP ALM, TCU, and/or JIRA preferred