More than just another design shop or contract manufacturer, Cirtec offers a uniquely comprehensive range of vertically integrated capabilities. Cirtec specializes in complex, difficult to produce components and devices in today's most advanced product technologies including, neuromodulation, implantable drug delivery, cardiac rhythm management, ventricular assist and interventional devices and delivery systems. We have the capabilities needed to bring products to full production, including assembly, packaging and testing, and in-house sterilization.
Our employees have the expertise needed to design innovative devices, solve complex design challenges, and help bring our customers' devices to market. If you are interested in working in a fun, challenging, fast-paced environment with a company that is growing and providing leading edge technology, Cirtec is the company for you!
The engineering team consisting of other engineers with diverse backgrounds and expertise. The Engineering team works in close collaboration with Operations, R&D, and Purchasing. You will be involved in the design, development, documentation and validation of new customer products, and modification of existing products including defining requirements, timelines, and deliverables with a focus on prototypes, process development, design verification, clinical builds, training production, and preparation for process validation and manufacturing transfer of products.
The Sr. Engineer, Embedded Firmware position is responsible for software development for Class II and III medical devices. This position will lead embedded firmware development in the area of medical device manufacturing and development of neuromodulation platforms and ASICS. This position will develop code to operate active and passive implantable/external medical devices. This individual will work with a multi-disciplinary engineering team including software, electrical and mechanical hardware engineers, and all other functions of the company to ensure high quality and on-time product introductions. This team player will have experience with multi-tasking in a high energy face paced environment.
- Utilize UML tools, cross compilers, and version control tools to design and create embedded firmware
- Create and review test software requirements
- Oversee and direct the work of contractors assigned to the project
- Assist in the mechanical and electrical design of devices
- Architect, develop and execute the firmware
- Develop user and system documentation
- Participate in produce development meetings and software/hardware design and risk analysis reviews
- Specify and assemble development prototypes
- Ensure that medical device components are compliant with applicable international standards and requirements
- Maintain software/hardware design history files and participate in periodic phase reviews
- Report defects to the stakeholders
- Provide inputs to the team in order to improve the medical device design
- Reliable, consistent, and punctual attendance is an essential function of the job.
- Complies with company, quality, and safety standards, policies, and procedures.
- Other duties as assigned
This is not a remote position.
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.
- A Bachelor's degree (STEM engineering discipline preferred) and 5 years of experience required; or a combination of education and relevant work experience.
- Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
- Working knowledge in electronics, analog, power and digital, oscilloscopes, and general electronic test equipment.
- Working knowledge of implantable/external medical devices and their interfaces.
- Must be able to read, write and speak fluent English.
- Excellent oral, written, and presentation communication skills.
- Experience in development of firmware for active implantable devices
- Experience with the medical device IQ, OQ, PQ test stand progression
- Familiarity with medical development standards such as IEC 60601-1, 62304,60601-1-2, ISO 14708-1, 14708-3
- SysML, UML and MBSE knowledge
- Knowledge of quality control principles and methodology
- A fast-paced work environment
- Paid time off
- 401(k) retirement savings with a company match
- Clean, and well-lit production areas
- Training and career development, with onboarding programs for new employees and tuition assistance
- Financial security through competitive compensation, incentives and retirement plans
- Health care and well-being programs including medical, dental, vision, wellness and occupational health programs
Work is performed in an office environment. The noise level in the work environment is usually moderate. The work environment characteristics described here are representative of those individual encounters while performing the essential functions of this position.
Cirtec Medical Corporation is an Equal Opportunity Minority/Female/Individuals with Disabilities/Protected Veteran and Affirmative Action Employer
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 application process.
What We Do
Whether you’re a cutting-edge startup or a leading Class II or III medical device manufacturer, Cirtec is here to help bring life-enhancing therapies to market – quickly and cost-effectively. Our staff of engineers and manufacturing experts can help you succeed at any or every stage of your product development cycle, including design/development, pilot and clinical build, manufacturing and finished device assembly.
Cirtec brings three decades of experience in developing medical devices fabricated under 21 CFR 820 and ISO 13485 quality standards. Our dedicated program management experts are here to help you bring your product from concept through commercialization – on time, on budget and as seamlessly as possible.