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This position works on projects of medium complexity, or under the guidance of a higher level Systems Engineer on higher complexity projects, and works cross-functionally in the engineering dept. This position works closely with the engineering technical leaders to provide feedback and updates on Systems Engineering tasks and timelines, resource needs and limitations. This role ensures that risks are identified and evaluated, discussed, and leads risk documentation. This role plays a key role in requirements gathering and working cross functionally to define system requirements and specifications. They also play a vital role in inputting data and maintaining our ALM system where the data will be stored. This role works with the team to develop and define the system design, architecture and system integration. They work with the team members to develop test plans for verification and validation.

This position has the responsibility to lead and participate in UL, EMC, and other regulatory testing as needed. This position will be responsible during the development of the product for material compliance management and working with the team to obtain and meet REACH, RoHS, etc.

Primary duties include:

+ Provide Systems Engineering technical guidance for projects throughout the phases of research and development, from proof of concept to design and/or to support of new and/or current technologies or products.

+ Work with Design and Test Engineers to develop and create test plans for Verifications and Validations to ensure products requirements and specifications are met.

+ Understand regulatory guidance to be able to work with teams to ensure proper implementation of design controls, including risk management, design verification, and validation activities.

+ Design history file creation: Support generation of design history files (DHF) to document the design and development process, ensuring compliance with regulatory standards. Organize and compile relevant design documentation, including design inputs, outputs, verification, and validation records.

+ Collaborate with cross-functional teams both business and technical partners: Work closely with cross-functional teams, including design engineers, quality engineers, regulatory specialists, and manufacturing teams, to foster collaboration and ensure effective communication throughout the product development lifecycle.

Additional information about this position:

+ Works on medium complexity projects.

+ Generally, works on a team with other engineers.

+ Receives moderate oversight from a Senior Systems Engineer.

+ Travel <5%

+ Must wear PPE throughout the day

Minimum Qualifications:

Education & Experience:

+ Bachelor's Degree in Engineering

+ 5 year's experience in an engineering role

Knowledge, Skills, Abilities:

+ Solid experience in the medical device industry, specifically in research and development.

+ Strong knowledge of product development processes and methodologies.

+ Excellent analytical and problem-solving skills.

+ Ability to develop clear and concise reports.

+ Experience in creating design verification plans, test cases, and conducting testing.

+ Familiarity with reliability test planning and execution.

+ Understanding of design controls and regulatory requirements.

+ Ability to create and maintain design history files (DHF).

+ Strong interpersonal and communication skills, with the ability to collaborate effectively with cross-functional teams.

+ Familiarity with regulatory requirements and quality management systems in the medical device industry.

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