Description

Please note - Sponsorship or transfer of sponsorship, including OPT/F1 Visas, is not available for this role.
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.
Our dedicated teams prioritize growth, innovation, and collaboration. We actively seek opportunities for improvement to enhance our support for clients. If you embrace a growth mindset and thrive on challenges, you may be a perfect fit for our team!

Position Summary:

The Principal Systems Engineer will be responsible for system-level development and implementation of electronic, software, and mechanical designs for Class II and III medical devices. The Principal Systems Engineer 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 fast paced environment. The person needs to have strong self-starting qualities to independently manage coordination of multiple projects to ensure timely and successful completion. Must be enthusiastic, positive, even tempered and have strong skills in areas of dependability, interpersonal relationships, and communication.

Key Responsibilities:

• This position may have direct-reporting responsibilities for daily activities of site Engineering personnel (responsibility dependent on geographic organizational structure).
• Creates requirements, engineering specifications, tests during the life cycle of the product development and develops technical solutions based on these requirements to be implemented by the different disciplines (electrical, mechanical, etc.).
• Applies medical development standards, such as IEC 60601-1, 62304, 60601-1-2, ISO 14708-1, 14708-3, ISO 13485
• Ensure that all requirements and specifications are being met, and that all elements are being developed to maximize performance, reliability, and serviceability within the constraints of the project schedule and budget
• Perform detailed design analysis and conduct regular design reviews with all the disciplines
• Collaborate with program managers to create and manage development plans and project plans related to the development
• Lead and contribute to creation of risk management documentation, including Failure Mode Effects Analysis
• Develop and maintain documentation (e.g., specifications, designs, test plans and reports, etc.) required for medical product Design and Development Files. Assist in creation of manufacturing process instructions, bills of material, quality inspection, and related documentation
• Lead product development meetings for the associated disciplines
• Maintain Design and Development file and participate in periodic phase reviews.
• Create reports for the stakeholders

Must Have:

• A Bachelor’s degree in a STEM discipline
• 10 years of relevant experience required
• Experience in an engineering environment with mechanical, tool design, and manufacturing processes (medical device preferred).
• Experienced with Quality Control principles and methodology
• Meticulous attention to detail, including ability to maintain accurate records and traceability.
• Analytical reasoning and problem solving
• Experience in developing requirements, engineering specifications, procedures
• Team player and goal oriented
• Knowledge of Agile development methodologies (Scrum, Kanban)
• Must be able to read, write and speak fluent English
• Knowledge of Quality Management System principles and methodology
• Excellent oral, written, and presentation communication skills

Good to have:

• Prefer Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
• SysML, UML and MBSE, INCOSE ASEP or CSEP preferred
• JAMA Product Development Documentation Management helpful
• Prefer experience in electronics: analog, power and digital, oscilloscopes, general electronic test equipment.

Competitive market salary from $150,000 to $180,000 per year depending on qualifications 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 application process.

We work to create a culture that is built on innovation, respect, transparency and communication, and hope you take pride in being a member of our team. It is Cirtec’s goal to create a great work environment and to keep the company a great place to work. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage. Our benefits include Training and career development, Healthcare and well-being programs including medical, dental, vision, wellness and occupational health programs, Paid Time Off and 401(k) retirement savings with a company match.