JOB SUMMARY

Vertically integrated, full-service outsource partner, bringing more than three decades of expertise to every phase of the product development lifecycle for complex medical devices, including state-of-the-art product design, development and manufacturing. We partner with our customers to bring medical devices to market quickly, predictably and cost-effectively.

We are actively looking for a Senior Mechanical Engineer who can bring innovation and creative thinking to the team. As a Senior Mechanical Engineer, you will lead product development teams to bring complex designs from concept to market. You will play a key role in the development of novel medical devices including state of the art minimally invasive catheter-based devices, delivery systems for implants, and other complex medical devices.

ESSENTIAL RESPONSIBILITIES

• Lead product development of complex mechanical and electromechanical medical devices through various phases of concept feasibility, detailed design and verification
• Lead creation of product requirements and design specifications, and determine applicable regulatory standards and ensures appropriate integration into product requirements
• Generate and maintain computer-aided drawings (CAD) using SolidWorks, schematics and component specifications to document mechanical designs
• Drive hands-on fabrication and testing of prototypes using bench testing, animal and/or cadaver studies to evaluate product designs, and recommend and implement design modifications
• Perform detailed design reviews and tolerance analyses to achieve product performance, cost, reliability and manufacturability requirements
• Serve as the main technical contact with customers and communicate directly with customers to understand project / product needs, and present technical updates, risks and issues
• Effectively interface with and manage suppliers to fabricate prototype and final components
• Develop test plans and protocols, and executes prototype testing and design verification testing
• Lead and contribute towards creation of risk management documentation, including FMEAs
• Create engineering-level manufacturing process instructions, bill of materials and related manufacturing documentation
• Proactively anticipate technical risks and issues, and formulate and implement risk mitigations and corrective/preventive actions
• Assist program managers in developing and maintaining project plans, and in tracking program health in terms of schedule, budget, and technical risks and issues
• Collaborate with cross-functional team members to create and maintain Design History file per internal company procedures, FDA Design Control (21 CFR 820) and ISO 13485 requirements
• Mentor and provide guidance to other engineers and technicians
• Other duties as assigned

An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.

QUALIFICATIONS

• BS in Mechanical / Biomedical Engineering with minimum 5 years of experience within the Medical Device industry
• Extensive knowledge and experience with product development of medical devices
• Strong understanding of mechanical component manufacturing (i.e. injection molding, extrusion, etc.)
• Proven experience and proficiency using SolidWorks for mechanical design
• Strong working knowledge and understanding of GD&T and mechanical design standards
• Excellent communication skills, both written and oral