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The Senior Principal Systems Engineer will serve as a Product Design Owner (PDO), a technical owner for the design and integration of infusion pump systems and/or projects, which combine electro-mechanical hardware, embedded software, and user interface components, as well as the interface with other related EM and/or digital products. The PDO drives operational excellence and predictable, consistent execution in our products, and design integrity. The PDO is accountable for product safety, performance, reliability, usability and regulatory compliance, and is the final decision authority on system architecture, requirements, interfaces and technical risks and trade-offs, and system behavior. The PDO drives design decisions, manages design control activities, and collaborates across engineering disciplines and cross-functions to deliver robust, reliable, safe and innovative infusion therapy solutions.
Job Responsibility
Leads interdisciplinary design and development of medical products in compliance with FDA, EU MDR, ISO 13485 and other global regulatory standards
Has final technical decision authority, leads trade-off analysis and makes critical decisions
Accountable for overall product safety, performance, compliance, usability, reliability and quality
Accountable for and drives overall product requirements, architecture, interfaces and product design realization
Understands and resolves competing constraints while driving collaboration of the technical team
Ensures product manufacturability and serviceability
Accountable for content and robustness of design reviews and program design changes
Directs and mentors the technical team to complete projects on schedule
Accountable for development of technical portion of schedule in conjunction with PMO
Fosters a creative, collaborative and innovative environment
Requirements
Has led the transfer of at least one project
Must have good working knowledge of regulations and standards affecting medical devices and have experience with products under design control
Bachelor's degree in engineering (Mechanical, Electrical, Software, or similar) with 8+ years of experience
Minimum of 5 years of relevant experience in medical device manufacturing industry
What we offer
Support for Parents
Continuing Education/ Professional Development
Employee Heath & Well-Being Benefits
Paid Time Off
2 Days a Year to Volunteer
Medical and dental coverage that start on day one
Insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance
Employee Stock Purchase Plan (ESPP)
401(k) Retirement Savings Plan (RSP)
Flexible Spending Accounts
Educational assistance programs
Paid holidays
Paid time off ranging from 20 to 35 days based on length of service