ICU Medical · 2 weeks ago
Manager, Engineering - Quality
Lake Forest, IL
Full-time
Onsite
Mid, Senior Level
$120K/yr - $172K/yr
8+ years expICU Medical is a global leader in IV therapy and critical care products, seeking a Manager of Engineering - Quality to oversee quality assurance processes for new product development. This role involves providing leadership to Quality Engineers, ensuring compliance with quality systems, and managing product life cycle activities to guarantee safe and effective medical devices.
Health CareMedical Device
Responsibilities
Provide effective tactical Quality leadership for Quality Engineers
Interact and communicate with Senior Leadership across ICU Medical regarding program status, risks, mitigation plans and business objectives
Effectively deploy and assure compliance with ICU Medical’s Quality System such as Design Controls, risk analysis/management tools, design verification, design validation, investigations, CA/PA data, etc. to assure product quality
Support design and manufacturing site inspections/audits, representing and defending Design Control compliance for medical device products
Assure systems conform to all applicable US and international regulatory requirements and coordinate development of data and responses for regulators
Understand medical device regulations and assure ICU Medical Quality Systems and documentation remain compliant
Ensure all Quality attributes for design changes and fixes are met. Work with cross-functional teams to coordinate product changes
Provide design quality support, guidance and direction for all manufacturing facilities including driving/managing on-market product issues to closure and escalating to senior management for support as necessary
Define, evaluate, prioritize and correct potential product and process risks to drive continuous quality improvements
Represent the Quality organization as the core team member on Platform/Business teams
Work with on-market teams regarding product life-cycle management and change management
Qualification
Required
Demonstrated leadership capabilities with strong inter-personal communication capabilities
Ability to communicate at all levels of the organization regarding project and business objective status, risks and recommendations/mitigations
Demonstrated knowledge of Quality Management Systems and experience linking risk management to all elements of the Quality System (Design Controls, CAPA, Complaints, Document Control, etc)
Systems level product development experience with an appreciation for interactions of the design and risk of components, materials, drugs and manufacturing processes. Inclusive of the interaction of user needs, requirements and how they link to specific test cases and design inputs and outputs
Excellent knowledge of the philosophy and principles of quality engineering, design verification, design validation, risk management and quality management
Demonstrated problem solving and decision-making skills
Strong understanding of failure analysis, test method validation and engineering tolerances
Broad knowledge of manufacturing operations and quality system practices
Must be at least 18 years of age
Bachelor's degree from an accredited college or university is required in Mechanical Engineering, Bio Engineering, Materials Science, Physics required
8 years of regulated industry experience required, preferably in a quality or compliance position of technical quality assurance experience in a related field
2 - 4 years of management or supervisory experience
Benefits
Competitive financial benefits, including a generous 401(k) match and (for eligible roles) our Annual Incentive Plan
A wide range of benefit options at affordable rates
Additional perks to assist employees with their work-life effectiveness, such as Paid Time Off, Company Holidays, and Tuition Reimbursement
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