- Create requirements, engineering specifications, tests during the life cycle of the product development
- Applies medical development standards, such as IEC , 62304, ,
ISO , , 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.
- Use a thorough, systematic, open approach to problem-solving.
- 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.
- 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).
- 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
- 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
- Engineering experience with active and passive implantable devices and peripherals for Class III medical devices.
- SysML, UML and MBSE
- INCOSE ASEP or CSEP
- JAMA Product Development Documentation Management
- Experienced in electronics: analog, power and digital, oscilloscopes, general electronic test equipment.
- 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
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Senior Systems Engineer - Brooklyn Park, United States - Cirtec Medical
Description
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 Sr. Engineer, Systems will be responsible for system-level development and implementation of electronic and software designs for Class II and III medical devices. The Sr. 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.
ESSENTIAL RESPONSIBILITIES
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
PREFERRED QUALIFICATIONS
WHAT WE OFFER
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.
