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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 to enhance patient outcomes
Accountable for end-to-end system traceability completeness
Has final technical decision authority, leads trade-off analysis and makes critical decisions
Ensures technical risks are anticipated and identified, mitigations implemented and aligned with product objectives at all stages of a project
Works in close collaboration with Product Risk Owner
Accountable for overall product safety, performance, compliance, usability, reliability and quality in the delivered product
Accountable for and drives overall product requirements, architecture, interfaces and product design realization, ensuring inclusion of inputs from all stakeholders
Understands and resolves competing constraints while driving collaboration of the technical team as well as cross-functionally (engineering, manufacturing, regulatory, clinical, commercial, etc) throughout the product lifecycle
Ensures product manufacturability and serviceability
Accountable for content and robustness of design reviews and program design changes, and compliance with PDLM processes and procedures, including DHF documentation and audit and regulatory submissions technical preparation
Directs and mentors the technical team to complete projects on schedule, ensuring budget goals are met, and all deliverables are of expected quality
Accountable for development of technical portion of schedule in conjunction with PMO
Fosters a creative, collaborative and innovative environment including focus on innovation and continuous improvement
Requirements:
Bachelor's degree in engineering (Mechanical, Electrical, Software, or similar) with 8+ years of experience
Must have good working knowledge of regulations and standards affecting medical devices
Experience with products under design control
Has led the transfer of at least one project
Minimum of 5 years of relevant experience in medical device manufacturing industry
Applicants must be authorized to work for any employer in the U.S.
What we offer:
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), with the ability to purchase company stock at a discount
401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching
Flexible Spending Accounts
Educational assistance programs
Time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service