SHOULD WORK IN W2ONSITE - USC/GC/H4EAD/ L2EAD
Key Responsibilities:
Mechanical and Electrical Expertise: Design, develop, and sustain mechanical and electrical systems for medical products, including sterilization and temperature monitoring equipment and biological indicator incubators.Change Control Process: Manage and execute change control processes to ensure compliance with regulatory standards and maintain product quality.Cross-Functional Team Collaboration: Work closely with quality, regulatory, manufacturing, and supply chain teams (both internal and external) to execute and implement tasks and drive projects to completion.Alternate Part Identification: Identify and qualify alternate parts to ensure product continuity and cost efficiency.Global Team Coordination: Coordinate with global teams, including onsite and offshore resources, to ensure seamless project execution and communication.Project Management: Lead and manage projects, ensuring timely delivery and adherence to quality standards.Documentation and Compliance: Maintain detailed documentation to support compliance with regulatory requirements and internal standards.Qualifications:
Education: Bachelor's degree in Engineering is required; a Master's degree in Engineering is preferred.Experience: Minimum of 10 years of experience working with medical device manufacturers.Skills:
Strong mechanical and electrical engineering skills.In-depth knowledge of sterilization and temperature monitoring systems.Proven experience with change control processes.Ability to work effectively with cross-functional teams.Experience in identifying and qualifying alternate parts.Strong project management and leadership skills.Excellent communication and coordination skills for global team management.Regulatory Knowledge: Familiarity with regulatory requirements and standards for medical devices (e.g., ISO 13485, EU-MDR).#J-18808-Ljbffr
