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Job Description

Insight Global is looking for a talented Senior Design Assurance Engineer to join our innovative team. This role involves ensuring that our product designs meet rigorous quality and safety standards throughout the development process. You'll collaborate closely with cross-functional teams to define and implement best practices in design assurance.

DUTIES AND RESPONSIBILITIES:

• Lead the design assurance activities and support product development through design verification and validation.

• Develop and execute risk management and design control documents, including DHF, DMR, and technical files.

• Drive the creation of test protocols and reports, ensuring compliance with regulatory and industry standards.

• Analyze testing data and prepare technical documentation for submissions to regulatory bodies.

• Oversee design reviews and provide constructive feedback to team members.

• Stay updated on industry trends and regulatory changes to continually enhance design assurance practices.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances. If you need assistance and/or a reasonable accommodation due to a disability during the application or recruiting process, please send a request to [email protected] learn more about how we collect, keep, and process your private information, please review Insight Global's Workforce Privacy Policy: https://insightglobal.com/workforce-privacy-policy/.

Skills and Requirements

• Bachelor’s Degree in Engineering or a related field; Master’s preferred.

• Minimum of 5 years of experience in design assurance within the medical device industry.

• In-depth understanding of design control and risk management principles.

• Proven experience with FDA, ISO, and IEC regulations and standards.

• Proficient in statistical analysis software and methodologies.

• Strong communication skills and ability to work collaboratively in cross-functional teams.

• Demonstrated problem-solving abilities and attention to detail.