Job Description

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).

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