Systems Engineer II

This position is eligible for a $5,000 sign on bonus.

ABOUT THE COMPANY

Cirtec Medical is more than just another design shop or contract manufacturer, we offer a uniquely comprehensive range of vertically integrated capabilities.

Cirtec Medical 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!

You are a part of :

The Engineering team consists of 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.

JOB SUMMARY

The Engineer II, Systems will be responsible for system-level development and implementation of electronic

and software designs for Class II and III medical devices. The Engineer II, Systems 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.

ESSENTIAL RESPONSIBILITIES

Create requirements, engineering specifications, tests during the life cycle of the product

development

Applies medical development standards, such as IEC 60601-1, 62304, 60601-1-2,

ISO 14708-1, 14708-3, ISO 13485

Ensure that all hardware and software 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 hardware and software

engineering teams

Collaborate with program managers to create and manage development plans and project plans

related to electronic and software systems 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 History Files. Manage and assist in creation of manufacturing

process instructions, bills of material, quality inspection, and related documentation

• Create, review test software requirements, architecture, develop and executing the test code.
• Participate in product development meetings and software / hardware design and risk analysis

reviews.

• Specify and assemble hardware for tests
• Maintain design history file and participate in periodic phase reviews.
• Create reports to the stakeholders and create test logs.
• Provide inputs to the team to improve the medical device design and test outcomes.
• Reliable, consistent, and punctual attendance is an essential function of the job.
• Use a thorough, systematic, open approach to problem-solving.
• 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.

QUALIFICATIONS

A Bachelor’s degree (STEM engineering discipline preferred) and 2 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)

• Meticulous attention to detail, including ability to maintain accurate records and traceability.
• Experienced with Quality Control principles and methodology
• Good communication and interpersonal skills
• Analytical reasoning and problem solving
• Experience in developing requirements, engineering specifications, procedures
• Team player and goal oriented
• Must have strong self-starting qualities to independently manage coordination of multiple projects to

ensure timely and successful completion

• Knowledge of Quality Management System principles and methodology
• Knowledge of Agile development methodologies (Scrum, Kanban)
• Engineering experience with active and passive implantable devices and peripherals for Class III

medical devices.

• Prefer knowledge of SysML, UML and MBSE, INCOSE ASEP or CSEP
• JAMA Product Development Documentation Management experience helpful
• Prefer experience in electronics : analog, power and digital, oscilloscopes, general electronic test

equipment.

Must be able to read, write and speak fluent English

WHAT WE OFFER

• 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

WORKING ENVIRONMENT

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 an individual encounters

while performing the essential functions of this position.

EEO STATEMENT

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.