Principal Mechanical Design Engineer, Implantable Leads

Description About us

For over three decades, Cirtec Medical has been a leading outsourcing partner for complex medical devices. We specialize in providing comprehensive solutions for Class II and III devices, from design and development to precision components and finished device assembly. Our expertise spans neuromodulation, implantable drug delivery, cardiac rhythm management, structural heart, mechanical circulatory support, and minimally invasive surgical systems.

The Principal Mechanical Design Engineer, Implantable Leads is primarily responsible for definition, design, development and testing of medical devices, with a focus on neuromodulation leads and related delivery systems. This individual will be responsible for translation of customer requirements into product designs and specifications while ensuring manufacturability and reliability of realized products. This individual will lead the design and development efforts for multiple development programs independently, acting as a technical lead and mentor to other engineers.

This individual is also capable of serving as a subject matter expert in several areas for the organization.

• Serve as the technical lead for the mechanical design and development of permanently implantable electrostimulation lead systems and associated delivery components.
  • Lead architecture development, concept selection, and design tradeoff analyses for implantable leads used in neural, cardiac, peripheral stimulation or brain computer interface (BCI) applications.
  • Provide technical direction across multidisciplinary development efforts involving mechanical, electrical, materials, manufacturing, and quality engineering teams.
  • Act as the primary technical driver for mechanical design challenges and complex failure investigations.
  • Drive technical strategy for long-term manufacturability, reliability, and regulatory compliance.
  • Host design reviews with internal and external stakeholders
• Lead detailed design of implantable lead systems including Lead bodies, tissue interfaces, connectors, and stylets.
  • Develop mechanical solutions for chronic implant environments emphasizing flexibility, fatigue resistance, biostability, and long-term reliability.
  • Lead development of implantable assemblies utilizing materials such as silicone, polyurethane, MP35N, PtIr, Nitinol, stainless steel, and fluoropolymers.
• Lead cross-functional collaboration across development, manufacturing and customer teams.
  • Interface directly with customers to translate clinical and product requirements into mechanical design requirements.
  • Collaborate with electrical and firmware teams to ensure robust electromechanical integration.
  • Work closely with customers to optimize implantability and procedural workflow.
  • Participate in cadaver labs, physician evaluations, and simulated use assessments with customer teams.
  • Work with manufacturing team partners to support prototype through commercial manufacturing process selections and implementation.
• Mentor engineering team(s) and drive implantable device design methodologies and best practices.
  • Manage a small team of direct engineering reports to drive progress on multiple technical programs.
  • Lead technical reviews and provide guidance across multiple development programs.
  • Influence engineering standards, design practices, and technology roadmaps within the organization.
  • Support intellectual property generation including invention disclosures and patent development.
  • Serve as a recognized subject matter expert in implantable lead technology.
• Manage workload to support various projects, in larger scale and complexity
• Comply with company, quality, and safety standards, policies, and procedures.

• Bachelor's degree in mechanical engineering or a similar STEM engineering discipline
• Minimum 10 years of experience required in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred); or a combination of education and relevant work experience.
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• FDA, cGMP, GDP principles and practices, (ISO 9001, ISO 13485)
• Proficiency with Solidworks required
• Knowledge of dimensioning and tolerances, GD&T
• Computer skills associated with Microsoft software
• Must be able to read, write and speak fluent English
• Excellent reading, writing, communication, and organizational skills

Salary Range: 140, based on skills and experience

Cirtec Medical Corporation considers for employment and hires qualified candidates without regard to age, race, religion, color, sex, sexual orientation, gender identity, national origin, ancestry, protected veteran or disability status or any factor prohibited by law. Cirtec Medical Corporation and all of its related companies fully endorse equal opportunity for all. Cirtec Medical provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in the job…