Senior Engineer, Design Quality

ICU Medical; San Clemente (CA); Hybrid; USD 141,000 - 161,000; Full time

Job summary

ICU Medical, Inc. in San Clemente, CA, is seeking a seasoned quality assurance professional to ensure FDA and international regulatory compliance across product development and post-market activities.

You will lead risk assessments, create Design V&V protocols, manage CAPA, and coordinate with cross-functional teams on changes, audits, and submissions.

Qualifications

• Bachelor’s degree in engineering plus 7 years in a related role.
• Knowledge of ISO 13485 and ISO 14971; FDA QSR regulations.
• Experience with Design Controls, CAPA, and Document Control.
• Experience supporting 510(k) and Technical File submissions.
• Ability to create Design V&V protocols and reports.
• Strong analytics and risk management documentation.

Responsibilities

• Assure FDA and international regulatory compliance for products.
• Coordinate product changes with cross-functional teams.
• Participate in design reviews, risk assessments and design transfers.
• Prepare for audits and inspections; support responses to regulators.
• Monitor data to identify trends and improve quality.

Skills

Quality Assurance

Regulatory Knowledge

Risk Management

Design Controls

CAPA Processes

Statistical Analysis

Education

Bachelor’s degree in Electrical Engineering, Mechanical Engineering, Biomedical Engineering, Software Engineering, or closely related field

Job description

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. 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 plus Seven (7) years of experience in the job offered or a closely related occupation.

Special Requirements

Must possess expertise/knowledge sufficient to adequately perform the duties of the job being offered. Expertise/knowledge may be gained through employment experience or education. Such expertise/knowledge cannot be “quantified” by “time.” Required expertise/knowledge includes: 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; 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.

ICU Medical, Inc. is an equal opportunity employer.

40 hours per week / $140,774 - $161,000 per year

Must reference JOB CODE: CA0606PS