The Role:

The Senior Systems Engineer will lead new product development for a growing medical device company. Responsibilities include managing engineering documentation, supporting design verification and validation, and coordinating with vendors, test labs, and internal teams. The role ensures that best practices and efficient processes are followed to achieve technical and business goals.

Must Haves:

• BS in Mechanical, Chemical, Plastic/Materials, Biomedical Engineering.
• 10+ years in medical device development
• Experience with mechanical, electrical, and software systems.
• Skilled in designing systems that integrate mechanical, electrical, and software components.
• Deep Knowledge of relevant standards (e.g., ISO 13485, ISO 14971, FDA QSR).
• Project Management experience.

Responsibilities:

• Lead the design and creation of a medical device, including its electrical, software, and mechanical components.
• Develop and implement project plans for product development.
• Define design concepts, incorporate marketing input, create design requirements, and support design testing and validation.
• Identify and manage necessary internal and external resources.
• Ensure that device development is aligned with catheter development to meet overall system requirements.
• Provide guidance and direction to engineers, technicians, and consultants involved in the device's design and development.
• Create and update design input and risk management documents. Assist with regulatory filings and patent submissions.
• Support testing and analysis at the system level to ensure the design meets requirements. Perform tests and analyze results to justify design decisions.
• Evaluate data against design specifications, suggest enhancements, and implement improvements to the product.
• Offer advice to other product development teams on regulatory compliance, quality systems, and supply chain management.