Senior Engineer, Quality

ICU Medical•Gary, CA

11d

About The Position

Provide quality support and assurance for ICU Medical product development. The Quality Engineer is responsible for development procedures and deliverables, ensuring compliance with ICU Medical quality system requirements and applicable regulations and standards, including ISO 13485, ISO 14971, 21 CFR Part 820, and other applicable requirements. The role also provides quality assurance support to product realization and manufacturing teams for system product lines that include electro-mechanical, software, and consumable components. As a Quality Core Team Member, this individual helps ensure products are developed and manufactured using appropriate processes to build the highest level of quality into products. The role uses quality tools and processes to support product safety, compliance, risk management, verification, validation, investigations, corrective and preventive actions, audits, regulatory submissions, and the resolution of on-market product issues. It works closely with engineering and cross-functional teams throughout product development and the product life cycle. This is largely a sedentary role in a professional office environment using standard office equipment. Travel is typically 5% to 10% of the time.

Requirements

Must be at least 18 years of age.
Bachelor’s degree in engineering (Electrical, Mechanical, Biomedical, or Software) or a related field from an accredited college or university.
At least 7 years of experience in quality engineering, product design, or product engineering in the medical device industry.
ASQ CQE or CSQE certification required, or the ability to obtain it within one year.
Expert quality compliance, audit, and investigation skills.
In-depth knowledge of Quality Management Systems and experience linking risk management to elements of the Quality System, including Design Controls, CAPA, Complaints, and Document Control.
Strong knowledge of medical device standards, including ISO 13485, ISO 14971, IEC 60601, and IEC 62304.
In-depth experience with and knowledge of FDA, MDR, and other key medical device regulations.
Ability to take a systems approach and understand interactions between hardware, software, and consumable components.
Proven ability to work closely with engineering teams and cross-functional team members.

Nice To Haves

New product development experience is strongly preferred.

Responsibilities

Manage product life-cycle activities to ensure product safety and compliance with quality system requirements.
Ensure alignment and consistency with ICU Medical’s quality system and development practices.
Use quality tools and processes, including product and process controls, risk analysis and management, validation, design verification, investigations, and CAPA data, to assure product quality.
Prepare for and support readiness for potential internal and external audits and inspections.
Conduct periodic project audits against SOPs and processes.
Participate in design reviews, test readiness reviews, cross-functional teams, risk assessments, code reviews, and unit test inspections.
Review, approve, and participate in qualification of acquired software and software tools.
Perform and support product risk analysis and management.
Use product review, global complaint, manufacturing quality, and other data sources to monitor product data and identify statistically significant trends and risks.
Support on-market issue investigations, risk assessments, and related CAPA activities.
Review and approve resolutions of on-market product issues.
Support regulatory submissions and responses to regulatory inquiries.
Work on special projects as assigned.