Sustaining Mechanical Engineer

Position Overview

The Sustaining Mechanical Engineer will perform and own all aspects of new product launches and support the product development process by working closely with the R&D team and manufacturing department. This position will oversee conformance to manufacturability, optimization, packaging, and documentation with adherence to all applicable standards.

Key Responsibilities

• Work collaboratively with operations to ensure the seamless and successful transition of engineering projects into production
• Support the validation process by troubleshooting projects and assisting in ongoing design changes.
• Responsible for product design, modification, and fixtures instrumentation to support manufacturing using SolidWorks for product launches.
• Work cross-functionally with team members in various departments, including QA, Manufacturing, Procurement, and R&D.
• Responsible for completing tasks on time and within budget.
• Take ownership of product launch reviews and investigate the root cause of high priority problems raised through customer complaint processes; manage change for drawings and specifications during new product launches.
• Generate work instructions for the manufacturing of new products using existing equipment, ensuring adherence to internal quality systems.

Required Qualifications

• Education: Bachelor of Science, Mechanical Engineering required
• Experience Required: 5 years of medical device design experience required
• Knowledge of Geometric Dimensioning & Tolerancing (GD &T), detailed drawings, and tolerance analysis
• Ability to implement DFM and DFA principles into product design
• Ability to write and develop protocols
• Requirements: Proven root cause analysis, problem-solving skills, and experience applying statistical techniques such as statistical process control, design of experiments, and other problem-solving methods are required
• Possess the ability to work in a hands on capacity
• Some travel required

Preferred Qualifications

• 2+ years of thermoplastic injection/press molding experience preferred
• Exposure to interventional radiology and biopsy product design is preferred
• Knowledge of Minitab, SolidWorks, and MS Project is an added advantage