ICU Medical · 2 days ago
Senior Manager, Engineering - Manufacturing
Southington, CT, United States
Full-time
Onsite
Senior Level, Lead/Staff
10+ years expICU Medical is a global market leader in IV therapy and critical care products. The Sr. Manager, Engineering provides leadership and technical support for the production of medical devices, ensuring compliance with engineering specifications and regulations while managing engineering projects and teams.
Health CareMedical Device
Responsibilities
Support production and ensure the continuity of manufacturing operations. Drive root cause analysis for non-conformance, long-term corrective actions and preventive measures. Evaluate and correct systemic issues
Work with Manufacturing and Maintenance personnel to improve performance of manufacturing systems, i.e. yield improvements, scrap reduction, MUV reduction, cycle time improvements, ergonomic issues and maintenance needs
Spearhead initiatives for continuous process and lean implementations. Assess yield issues and promote design and/or selection of equipment to reduce costs and improve quality
Manage all stages of multiple engineering projects. Promote attainment of organizational objectives through team members
Provide leadership and guidance for non-routine problems requiring substantial judgment in the independent evaluation, selection and adaptation of standard engineering techniques, procedures and criteria
Work with vendors and internal departments to obtain necessary resources, resolve inter-departmental issues and contribute toward organizational objectives
Provide direct management to a team of Engineers/Engineering staff, determine priorities based on business needs and resource availability
Conduct project/team meetings to resolve issues, determine current status, provide information and assess changes in priorities
Oversee preparation of documentation associated with engineering activities to include drawings/schematics, validation/capability testing, various new and revised operating procedures. Etc. Provide reports and presentations to management as required
Generate timelines and milestones to bring projects to completion on time and within budget
Model company values and support strategic initiatives
Perform other related duties as assigned or required
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
Bachelor's Degree in Engineering or Technology
10 years of experience in Medical Device Engineering/Technology, with 5 years in a management/supervisory/leadership role
Strong injection molding, tooling and automation background
Six-Sigma Methodology (DOE, Process Capability, Gage R&R etc.)
Lean Methodology to drive equipment and processing improvements/production efficiency
Knowledge of Solid Works and experience with ASME Y14.5, ISO and GD&T standards
Maintain thorough understanding of the clinical use/risk of the product
Thorough understanding of strength of materials, kinematics and dynamics, vibration, and fluid flow, as well as automation, plastic injection molding, part assembly, fixturing, testing and process control techniques
Knowledge of the Medical Device Industry and familiarity with associated regulations
Excellent problem solving and analytical ability
Preferred
MS or MBA desirable
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