Principal Systems Engineer

SUMMARY :

This position owns & performs the System Requirements and Risk management activities for either a new product under development or a family of dialysis devices as they are used in dialysis therapy, in accordance with the regulatory standards (main being ISO 14971) & requirements.

Roles & Responsibilities:

• As a member of cross-functional team, integrates cross functional inputs to delivery of a project of minor to moderate complexity
• Responsible for performing the activities associated with the System Requirements and Risk Management of one or more products in various stages of the product lifecycle from new product development to post market surveillance.
• Understands the user needs, derives the system requirements, authors the same, reviews with cross functional teams and maintains the same for any changes and traceability. Flows down the same to sub system requirements working with sub system teams.
• Performs risk assessment on an ongoing basis for any proposed design/material/process change or an observation in the field/service or manufacturing to determine the impact and need for any mitigation.
• Come-up with the recommended mitigation with the rationale.
• Ensure that no unacceptable risk goes undetected and unmitigated.
• Expedite, manage, and coordinate interrelated Risk Management activities across functions, within the constraints of human and financial resources and changing priorities.
• Participate in identifying and planning tasks, activities, and resourcing needs related to Risk Management.
• Facilitate an improved understanding of the interrelationship between Risk and Reliability.
• Working knowledge of FMEAs and standards applicable to Reliability Engineering.
• Provides subject matter expertise to product development teams to ensure Risk Management principles are applied throughout the development cycle.
• Leads Risk Management activities in coordination with other cross-functions like HW, SW, HF,
• Collaborates with Engineering, Manufacturing and Service organizations in the development of design FMEA, Process FMEAs and roll-up into Risk Management files.
• Creates and approves Design History File deliverables associated with Risk Management.
• Provides ongoing risk analysis and identification of required risk mitigations to ensure safe, effective product.
• Able to analyze risk/tradeoffs and make recommendations of appropriate path forward.
• Successfully influences stakeholders and cross-functional team members within the project.

Education, Experience & key attributes:

• Graduate degree in Engineering, with a minimum of 8 years of practical Electromechanical Medical Device Design experience, some of which is in Requirement and Risk management.
• Able to effectively manage and lead complex projects. Has led the Risk Management activities of at least one significant project.
• Sound knowledge identifying, authoring system requirements derived from user needs
• Sound knowledge of Risk management standard ISO 14971 and its application.
• Good understanding of medical device QMS ISO 13485 with experience of having worked in this environment.
• Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design controls, documentation controls, risk management, and validation.
• Demonstrated experience in creation of typical failure analysis deliverables (Hazards Analysis, FMEAs, FTAs, etc.)
• Requires a high level of independence and excellent interpersonal and communication skills.
• Able to prepare and make written and verbal presentations to cross-functional audiences as required.
• Team player
• Six Sigma Green belt or Black Belt (DFSS) certification preferred.

  Role & responsibilities

Preferred candidate profile