Senior Engineer, Design Quality

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.

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.
• Assure 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.
• Provide 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 on special projects as assigned.

Requirements

Bachelor’s degree (or foreign equivalent) in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field plus seven (7) years of experience in the job offered or a closely related occupation.

• Knowledge of the Medical Device Industry and experience in ISO and FDA QSR regulations, including ISO 13485 and ISO 14971.
• Knowledge of Quality Management Systems and 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.
• Experience 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.

Pay

$140,774 - $161,000 per year

Schedule

40 hours per week