Senior Principal Engineer, Infusion Systems

Role Overview

• Leads the development and revision of all product risk documentation per current industry standards and regulatory requirements.
• Collaborates with cross-functional team members to build Use and Design Failure Modes and Effects Analyses (FMEAs) and Risk Assessments
• Identifies, and verifies effectiveness of, risk control measures throughout the product lifecycle.
• Reviews risk management processes with other business units and leads adoption of best practices.
• Reviews Process FMEAs developed by contract and internal manufacturing teams.
• Participates in Risk Management Committee meetings, preparing information to be presented and capturing and tracking action items to closure.
• Leads compliance with, and continuous improvement of, internal risk processes
• Develops and updates the Safety Assurance Case in collaboration with Clinical Product Specialist, Human Factors Engineering and Regulatory Affairs.
• Performs additional R&D system engineering activities as needed including requirements management, architecture review, V&V strategy, and post-market surveillance
• Leads post-market surveillance activities to maintain accurate, updated risk management files including responsibility for MAUDE database reviews, complaints analysis and CAPAs ownership.
• Uses computer-based tools to manage versions of risk objects and traceability to requirements and specifications.
• Displays advance understanding of theories/practices utilized by own discipline and other disciplines outside the primary area of expertise to identify coverage of risks, requirements, architectural components, functions and performance.
• Evaluates results relative to product requirements, definitions and/or program goals.
• Applies standard techniques to solving difficult problems.
• Work independently with latitude for individual judgment.
• Exercises judgment within defined procedures and practices to determine appropriate action.
• Guides the conceptualization of new methodologies, materials, machines, processes or products.
• Generates innovative solutions to complex problems through the use of multiple disciplines and technical principles.
• Advise senior management regarding appropriate action.
• Works on solving complex issues within department, where analysis of situations or data requires an in-depth evaluation of variable factors.
• Erroneous decisions or failure to achieve goals may result in additional costs and serious delays in overall schedules.
• Routinely provide advice and assistance to team members regarding routine and unique problems.
• May supervise or direct Sr engineers and lower-level engineers on assigned projects.

Requirements

• Bachelor’s Degree in Engineering or similar related degree.
• 8 years’ experience in a related role achieving similar responsibilities within the medical device industry.
• Comprehensive understanding of the medical device development process.
• Excellent interpersonal skills including ability to work effectively in a matrix environment.
• High attention to detail and excellent oral and written communication skills.
• Excellent problem solving and organizational skills.

Benefits

• 401(k) plan with company contributions
• Paid vacation
• Holiday and personal days
• Employee assistance program
• Health benefits including medical, prescription drug, dental and vision coverage