What are the responsibilities and job description for the Systems Engineer position at Defibtech, LLC?

Defibtech is seeking a Systems Engineer responsible for guiding the development of innovative products through the application of domain expertise, development processes, and technical expertise. The Systems Engineer will analyze system challenges, identify the best solution to meet project needs, ensure the application of the development process, and participate actively in cross-functional project teams. This position is based at our Guilford, CT headquarters, hybrid capable, with flexibility to be onsite for project demands.

Core Responsibilities :

Gathers and evaluates user needs, product requirements, system, and sub-system level design specifications.
Documents and maintains product requirement structure and traceability, including review and incorporation of applicable compliance standards.
Collaborates with cross-functional team members to drive system architectural and integration design decisions.
Assists in developing Test Protocols to verify / validate product requirements and system usability.
Owns product Risk File, including but not limited to Risk Management Plan and System Hazard Analyses.
Supports engineers to create and maintain Failure Mode Effect Analysis (FMEA) documentation.
Participates in analyzing and troubleshooting customer complaints.
Optimizes systems to ensure quality product designs that meet testing (verification / validation), regulatory, manufacturing, reliability, service, and cost targets.
Maintains domain and therapy expertise for defibrillation and resuscitation devices.
Demonstrates Defibtech's values on the job, promoting and participating in continuous improvement.
Actively supports compliance of Company operations to all applicable laws, regulations and standards, good business practices and company documented procedures (including but not limited to FDA, Quality Systems Regulations, safety regulations and applicable statutes).

Qualifications / Requirements :

Bachelor's degree in technical discipline such as engineering, plus practical experience through applicable engineering design projects is required.

Practical experience generating technical documentation such as product requirements, specifications, risk analysis, test protocols and reports is required.

Experience in medical product development within a regulated environment, with FDA and ISO medical device design controls requirements, and with medical device compliance standards (e.g., IEC 60601), is highly preferred.

Experience with DOORS or similar requirements management tools is highly preferred.

Familiarity with complex electro-mechanical products that include digital and analog electrical hardware and embedded software is highly preferred.

Strong documentation skills including generating requirements, specifications, test protocols, work instructions, workflow diagrams, etc.

Strong written and oral communication skills to accurately convey challenges, requests, status updates, and information.

Ability to work independently and drive tasks to successful completion.

Demonstrated ability to work within several cross-functional design teams to prioritize the completion of complex design projects, on time and within budget.

Work Environment and Physical Demands :

Work is primarily based in an office and within an engineering lab setting.

Occasional travel may be necessary (

Light work that includes moving objects up to 20 lbs; frequent walking / standing and sitting.

Ability to sit for prolonged periods at a desk, actively using a computer keyboard and monitor to perform job duties.

Manual dexterity, motor skills and use of hands required for benchwork and tools.

Ability to bend and reach for conducting benchwork.

Compensation and Benefits :

Defibtech offers competitive salaries and a comprehensive benefits package including core health benefits, company-paid disability, and a company matching 401k plan.

Defibtech promotes a challenging, collaborative, and friendly culture that is centered around our values : Passion, Innovation, Integrity, and Ownership.

Defibtech is supportive of work balance providing company gatherings to add fun and generous paid time off and flexibility for employees to manage time and responsibilities.

Defibtech is committed to empowering and supporting our employees in their philanthropic efforts through donation programs and time off for volunteerism.

Defibtech is committed to a diverse workplace and is an Equal Opportunity / Affirmative Action employer and E-Verify Company. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

The above description of core responsibilities and qualifications are intended to describe the general nature and level of the work being performed, but they are not an exhaustive list of all the required responsibilities and skills of this position. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.

Defibtech endeavors to make www.defibtech.com accessible to all users. If you would like to contact us regarding the accessibility of our website or need assistance completing the application process, please contact Human Resources at 203.453.6654. This contact information is for accommodation requests only and should not be used to inquire about the status of applications.

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