ICU Medical · 15 hours ago
Senior Engineer Design Quality - Consumables
Southington, CT, United States
Full-time
Onsite
Senior Level
7+ years expICU Medical is a company focused on medical devices, and they are seeking a Senior Engineer Design Quality for Consumables. The role involves ensuring product quality through the utilization of quality tools and processes, compliance with FDA regulations, and collaboration with cross-functional teams on product changes.
Health CareMedical Device
Responsibilities
Effectively utilize quality tools and processes such as product and process controls, risk analysis/management tools, validation, design verification, investigations, CAPA data, etc. to assure product quality
Assures conformance with regulations of the FDA and other international regulatory agencies and may assist in providing responses to the FDA and other regulatory agencies with respect to medical device compliance
Provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system
Work with cross-functional teams to coordinate product changes
Participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc
Provide corporate quality support, guidance and direction for brining on-market product issues to closure and escalating to senior management for support as necessary
Ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality
Utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. Monitor product data to identify statistically significant trends and risks
Ensure compliance, alignment and consistency with ICU Medical’s quality system
Prepare, support and ensure the readiness for any potential internal and/or external audits and inspections
Work special projects as assigned
Qualification
Required
Bachelor's degree in engineering (Electrical, Mechanical, Biomedical, Software) from an accredited college or university is required
Minimum of 7+ years of experience in R&D or Quality is required
ASQ CQE or CSQE required or the ability to obtain within one year
Expert quality compliance, audit, and investigation skills
In depth deep and broad knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc.)
Strong knowledge of medical device standards, including but not limited to: ISO 13485, ISO 14971
In depth experience with and knowledge of FDA, MDR, and other key medical device regulations
Well-developed ability to take a systems approach and to understand the interaction between components (i.e. hardware, software, consumables)
Proven ability to work closely with engineering and manufacturing team members
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 (20)
2024 (14)
2023 (27)
2022 (32)
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