Job Details

We are seeking a Sustaining Engineer to join our team . In this role You Will Play a crucial role in maintaining and optimizing manufacturing operations through close collaboration with contract manufacturers (CMs).

This position focuses on ensuring product quality, managing manufacturing documentation, and supporting continuous improvement initiatives.

Primary Responsibilities:

• Manage and maintain regular communication with contract manufacturers, including leading weekly status meetings to review production metrics and address manufacturing challenges.
• Monitor and analyze monthly manufacturing yields and throughput data to identify trends and areas for improvement in the production process.
• Lead root cause investigations into manufacturing defects, developing and implementing corrective actions in collaboration with the CM team.
• Create and maintain detailed manufacturing instructions and documentation to ensure consistent product quality across production runs.
• Write and manage deviation requests for test lots at contract manufacturing facilities, including coordination of builds and result analysis.
• Generate and maintain 2D mechanical drawings for components and assemblies as needed for production.
• Manage the Arena PLM system, including maintaining accurate part data and documentation.
• Design and create packaging labels according to product specifications and regulatory requirements.
• Develop and implement new Bills of Materials for product variants, including color SKU launches.

Required Skills and Qualifications:

• Bachelor's degree in Industrial Engineering, Mechanical Engineering, or related field with 3+ years of experience in manufacturing or sustaining engineering.
• Proficiency in mechanical CAD software and 2D drafting tools, with demonstrated technical drawing expertise. Solidworks is the Preferred package.
• Experience with PLM systems, particularly Arena or similar platforms.
• Strong analytical and problem-solving skills, with experience in manufacturing process improvement and quality control methodologies.
• Excellent project management abilities with demonstrated experience managing multiple concurrent projects.
• Strong technical writing skills for creating manufacturing documentation and specifications.
• Proven ability to analyze and interpret manufacturing data and metrics.
• Outstanding communication and interpersonal skills, with experience managing supplier relationships.
• Experience working in regulated manufacturing environments with strict quality requirements.
• Knowledge of Medical Device manufacturing and ISO13485 requirements.
• Knowledge of packaging and labeling requirements in a manufacturing context.