Senior System Engineer - Medical Products

Job Requirements

Quest Global is an organization at the forefront of innovation and one of the world's fastest growing engineering services firms with deep domain knowledge and recognized expertise in the top OEMs across seven industries. We are a twenty-five-year-old company on a journey to becoming a centenary one, driven by aspiration, hunger and humility.

We are looking for humble geniuses, who believe that engineering has the potential to make the impossible, possible; innovators, who are not only inspired by technology and innovation, but also perpetually driven to design, develop, and test as a trusted partner for Fortune 500 customers.

As a team of remarkably diverse engineers, we recognize that what we are really engineering is a brighter future for us all. If you want to contribute to meaningful work and be part of an organization that truly believes when you win, we all win, and when you fail, we all learn, then we're eager to hear from you.

Position Overview:
We are looking for an experienced Senior System Engineer with hands-on expertise in mechanical and electrical systems for medical products. The ideal candidate will have a strong background in sterilization, temperature monitoring equipment, and biological indicator incubators. This role requires extensive experience in the change control process, cross-functional team collaboration, and global team coordination.
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).