Senior Mechanical Engineer

2 weeks ago

Lake Forest, California, United States ICU Medical Full time

Senior Engineer, Mechanical – Supplier Quality

Overview

The Senior Engineer, Mechanical will serve as the Supplier Quality Engineering Site Representative for ICU Medical. This role is crucial in overseeing the quality of incoming materials by addressing supplier non-conformances (NCs) and Supplier Corrective Action Requests (SCARs).

Key Responsibilities

  • Manage and resolve supplier quality issues, ensuring compliance with established quality management system (QMS) requirements.
  • Drive supplier change notices (SCNs) and prepare management review metrics, reports, and scorecards.
  • Provide support for critical issues including recalls, field alerts, and product investigations.
  • Maintain the Approved Supplier Listing (ASL) and perform supplier audits to meet regulatory standards.
  • Review and release incoming batch records as necessary.
  • Conduct root cause investigations using problem-solving tools such as 5 Whys and Ishikawa diagrams.
  • Ensure adherence to Quality System Regulations (QSR) and ISO standards.
  • Oversee non-conformance reports (NCMRs/NCRs) and Corrective and Preventive Actions (CAPAs) from initiation to closure.
  • Conduct Gemba walks to identify compliance risks and propose effective mitigations.
  • Collaborate with external suppliers to address quality concerns.
  • Create and present data analysis charts and management meeting slides to leadership.
  • Mentor junior engineers in technical writing and quality concepts.

Qualifications

A Bachelor's degree (or foreign equivalent) in Biomedical Engineering, Material Science Engineering, Mechanical Engineering, Electrical Engineering, or a closely related field is required, along with four (4) years of relevant experience in the job offered or a closely related occupation.

Special Requirements

Candidates must possess sufficient expertise and knowledge to effectively perform the duties of the position. This expertise may be acquired through employment experience or education and cannot be quantified solely by time. Required knowledge includes:

  • Familiarity with the Medical Device Industry and FDA QSR regulations, including 21CFR820 and ISO13485.
  • Understanding of automation, medical-device assembly, and manufacturing processes.
  • Proficiency in Six-Sigma Methodology, including Design of Experiments (DOE) and Process Capability.
  • Experience with Non-Conformances, Root Cause Investigation Tools, and CAPAs.
  • Knowledge of supplier change control and supplier qualifications.
  • Skills in engineering technical writing and interpreting engineering drawings.
  • Competence in statistical analysis using Minitab and measurement system analysis (MSA).

ICU Medical, Inc. is an equal opportunity employer.

EOE M/F/D/V

It is the policy of ICU Medical, Inc. to provide equal employment opportunities to qualified employees and applicants, regardless of race, color, religion, sex, national origin, age, physical or mental disabilities, military or veteran status, sexual orientation, or any other protected condition in accordance with applicable federal, state, and local laws.

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