ICU Medical · 5 hours ago
Senior Engineer, Product Development
Southington, CT, United States
Full-time
Onsite
Senior Level
7+ years expICU Medical is a global market leader in IV therapy and critical care products. They are seeking a Senior Engineer to support the Research and Development engineering team, focusing on the development and implementation of new products within the Consumables business unit, emphasizing Systems Engineering.
Health CareMedical Device
Responsibilities
Contributes to project planning: milestones, schedules, budgets, key decisions
Defines Systems Architecture, Document Hierarchy and DHF structure
Identifies and familiarizes with relevant clinical research, competitive landscape and prior art
Plans and executes Voice of the Customer activities, defines and translates User Needs to Design Input Technical Specifications
Defines applicable standards and regulations
Leads risk management activities such as Hazard Analysis
Contributes to design and process failure and effects analyses (DFMEA and PFMEA)
Maintains requirement, risk management, and verification / validation traceability
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 in collaboration with cross functional team
Performs characterization as required: establishes test plans, writes test protocols and methods, and authors test reports with data analysis and technical conclusions
Provides technical support to regulatory, sales, marketing and other functional areas as needed
Work on special assignments as they arise
Engages others, promotes, and participates in Environmental, Health, and Safety initiatives, focusing on continuous improvement
Experience with root cause analysis, CAPA and NCR processes
Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)
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
Minimum of seven years experience required
Ability to quickly learn new concepts and technologies
Proven hands-on experience developing medical devices in a gated development process
Knowledge of manufacturing processes: extrusion, injection molding, machining, metal forming, common joining methods, inspection, etc
Experimental, computational and analytical skills such as DFSS tools, MiniTab software and statistical methods including design of experiments (DOE)
Familiarity with ISO standards, including 13485, 14971, 62366, and 10555
Comfortable in clinical environments and understands product application: use cases, anatomy, physiology, biological interactions
Good interpersonal, verbal and written communications skills
Experience with root cause analysis, CAPA and NCR processes
Experience with global medical device regulations including FDA 510k and EU MDR (Medical Device Regulation)
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