Senior Mechanical Engineer

Overview:

We are seeking a highly motivated and experienced Senior Mechanical Engineer to play a vital role in the development of our cutting-edge medical implants and delivery systems.
You will lead the design, prototyping, testing, and manufacturing process, ensuring the creation of high-quality, innovative devices that meet stringent regulatory standards.
This role requires a collaborative approach, working closely with internal teams and external partners to bring life-saving technologies to patients.

Responsibilities:

• Product Development: Lead the development of cardiac medical implants and delivery systems, overseeing all stages from initial design to prototyping, testing, and manufacturing of functional devices.
• Tooling Design: Develop jigs and fixtures to support verification and validation (V&V) testing and streamline manufacturing processes.
• Quality Assurance: Maintain strict design control of development projects, ensuring adherence to established quality procedures and a structured QA environment.
• Problem-Solving: Analyze and troubleshoot design and manufacturing failures, implementing corrective actions to optimize performance and prevent future issues.
• Supplier Management: Oversee relationships with outsourced suppliers, manufacturers, and vendors, ensuring quality and timely delivery of components.

Qualifications:

• Education: Bachelor of Science degree in Mechanical Engineering.
• Experience:
  • Minimum of 5 years of experience in a medical device company, preferably with cardiovascular implants.
  • Proven experience in the design and development of Nitinol implants and delivery systems is highly desirable.
  • Strong understanding of QA procedures and relevant medical device standards (e.g., ISO 13485).
• Skills:
  • Strong proficiency in English (reading, writing, and speaking) for effective communication.
  • Excellent organizational skills with the ability to manage multiple projects simultaneously and prioritize tasks effectively.
  • Strong work ethic with the ability to work independently while also collaborating effectively with internal and external teams.