Systems Engineer II

We are looking for a dedicated Systems Engineer to join our team in Batesville, Indiana. This position involves contributing to the design, verification, and validation of complex medical devices, ensuring their safety and reliability throughout the product lifecycle. As a long-term contract opportunity, you will play a vital role in sustaining legacy products and supporting the development of new devices.

Responsibilities:

• Lead systems engineering efforts for sustaining legacy products and developing new medical devices.

• Develop and refine system requirements and architectures to address customer needs and project objectives.

• Create and execute verification and validation plans, including protocols, scripts, and regression testing.

• Collaborate with cross-functional teams to identify technical risks and propose effective mitigations.

• Produce detailed and high-quality technical documentation to communicate designs and processes.

• Contribute to product safety and security risk assessments, including DFMEAs.

• Utilize engineering tools and best practices to track metrics and ensure product and process compliance.

• Provide technical guidance during design reviews and assist in resolving engineering challenges.

• Stay informed about industry trends, market conditions, and competitive developments.

• Actively communicate updates and potential issues to stakeholders to maintain project alignment.

• Bachelor’s degree in Engineering or a related field.
• Minimum of 3 years of experience in systems engineering or a similar role.
• Strong problem-solving skills with the ability to generate alternative solutions.
• Excellent interpersonal skills and ability to collaborate effectively within a team environment.
• Proficiency in systems engineering tools such as Polarion and Minitab.
• Knowledge of medical device regulations and standards, including design control and risk management.
• Familiarity with systems involving electrical, mechanical, pneumatic, software, and wireless connectivity.
• Exceptional technical writing and communication abilities.
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