Senior Engineer, Quality

ICU Medical•Highland, IN

12d

About The Position

The Senior Engineer, Quality provides quality support and assurance for ICU Medical product development. The role 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, and 21 CFR Part 820. The Quality Engineer also supports product realization and manufacturing teams for system product lines encompassing electromechanical, software, and consumable components. As a Quality Core Team Member, the engineer helps ensure products are developed and manufactured using appropriate processes to build the highest level of quality into products. The position is largely sedentary in a professional office environment and routinely uses 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, 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 Quality System elements such as 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 among 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 compliance, 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.
Perform periodic audits of projects 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 data sources such as product reviews, global complaints, and manufacturing quality data.
Monitor product data to identify statistically significant trends and risks.
Support on-market issue investigations, risk assessments, and associated CAPA activities.
Review and approve resolution of on-market product issues.
Support regulatory submissions and responses to regulatory inquiries.
Work on special projects as assigned.