ICU Medical · 19 hours ago
Principal Engineer, Product Development
Southington, CT, United States
Full-time
Onsite
Lead/Staff
10+ years expICU Medical is a global market leader in IV therapy and critical care products. The Principal Engineer will support the Research and Development engineering team, leading the development and implementation of new medical device products while mentoring cross-functional teams.
Health CareMedical Device
Responsibilities
Understands product portfolio and contributes to pipeline strategy and road map
Is actively engaged in project planning: milestones, schedules, budgets, key decisions
Defines Systems Architecture, Document Hierarchy and DHF structure
Plans and executes Voice of the Customer activities followed by analyses and translation to detailed Design Input Technical Specifications
Defines applicable standards and regulations
Quickly identifies and familiarizes with relevant clinical research, competitive landscape and prior art
Invents practical solutions that advance the state of the art
Collaborate with Design and Manufacturing Engineers to develop functional prototypes
Plans feasibility, verification and validation activities with cross functional team
Defines test protocols and methods, and authors reports with data analysis and technical conclusions
Establishes and maintains requirement, risk management, and testing traceability
Able to lead risk management activities such as Hazard Analysis
Contributes to design and process failure and effects analyses (DFMEA and PFMEA)
Communications tailored to various audiences with appropriate frequency and detail to maximize utility and promote cross-functional collaboration
Completes additional duties and special projects as they arise
This position is required to assure compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including knowledge of all standards, government occupational health and environmental regulations and statutes related to the site)
Engage others, promote, and participate in Environmental, Health, and Safety initiatives, focusing on continuous improvement
Qualification
Required
Must be at least 18 years of age
Bachelor of Science degree from an accredited college or university in Mechanical or Biomedical Engineering or a related field
10+ years of experience
Ability to quickly learn new concepts and technologies
Good interpersonal, verbal and written communications skills
Proven hands-on experience developing medical devices
Experience leading projects through a gated development process
Comfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactions
Knowledge of manufacturing processes: extrusion, injection molding, machining, metal forming, joining methods, inspection, etc
Experimental, computational and analytical skills such as DFSS tools, MiniTab software and statistical methods
Experience with root cause analysis, CAPA and NCR processes
Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)
Familiarity with ISO standards, including 13485, 14971, 62366, and 10555
Preferred
Advanced degree in related field preferred
Company
ICU Medical
ICU Medical connects patients and caregivers through safe, life-saving, life-enhancing IV therapy systems, software, solutions, and consumables.
Founded in 2019San Clemente, California, USA
5001-10000 employees
H1B Sponsorship
ICU Medical has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (24)
2024 (14)
2023 (27)
2022 (31)
2021 (12)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
$1.3M2012-08-15Undisclosed· $1.3M
Leadership Team
Allison Knight
Human Resources Business Partner
Ben Sousa
Chief Information Officer
Company data provided by crunchbase