Senior Engineer, Design Quality

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 Medicals 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.

EDUCATION AND EXPERIENCE REQUIREMENTS:

Bachelors 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 / $140774 - $161000 per year

To apply for ICU Medicals Senior Engineer Design Quality position please send resume to:

Must reference JOB CODE: CA0606PS