Senior Engineer, Design Quality

ICU Medical•San Clemente, CA

13h•$140,774 - $161,000•Hybrid

About The Position

The Senior Engineer, Design Quality will 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. This role 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. The position provides compliance guidance concerning development, application, and maintenance of quality standards as related to product development within the quality system. The Senior Engineer will work with cross-functional teams to coordinate product changes and participate in design reviews, test readiness reviews, cross functional teams, risk assessments, design transfers, etc. This role will provide corporate quality support, guidance and direction for bringing on-market product issues to closure and escalating to senior management for support as necessary. The Senior Engineer will ensure that potential product and process risks are evaluated, prioritized, and mitigated to continuously improve product quality. This role will utilize a wide variety of data sources including product review, global complaints, manufacturing quality data, etc. The Senior Engineer will monitor product data to identify statistically significant trends and risks and ensure compliance, alignment and consistency with ICU Medical’s quality system. The role will prepare, support and ensure the readiness for any potential internal and/or external audits and inspections. Special projects as assigned will also be part of the responsibilities. Hybrid work from home is permissible. When not working from home, must report to San Clemente, CA office. 5-10% domestic and international travel required per year.

Requirements

Bachelor’s degree (or foreign equivalent) in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field
Seven (7) years of experience in the job offered or a closely related occupation.
Knowledge of the Medical Device Industry
Experience in ISO and FDA QSR regulations, including ISO 13485 and ISO 14971
Knowledge of Quality Management Systems
Experience linking risk management to all elements of the Quality System, including Design Controls, CAPA, Complaints, and Document Control
Experience in managing Design Control elements, Design History Files and Device Master Records
Experience in supporting 510K and Technical File submissions
Experience in creating Design V&V protocols and reports
Experiences in initiating and managing Risk Management documents (HA, DFMEA, PFMEA)
Familiarity with international regulations including REACH and RoHS compliances
Experience in investigations, risk assessments and associated CAPA activities
Knowledge in Statistical Analysis Techniques
Experience with Quality compliance, audit and investigation.

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 bringing 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.