Design Assurance Engineer

About Nuclein:

Nuclein is an Austin-based, private equity funded, medical device company that offers an innovative, FDA EUA authorized, rapid PCR, point-of-care system. The Nuclein® DASH™ Rapid PCR System is easy-to-use, affordable, and provides PCR results in only 15 minutes.

Our vision is to enable simple, affordable, rapid and accurate testing for everyone. We are a dedicated, talented and diverse team of scientists, engineers and experienced professionals who are driven to excel and make a significant contribution to the world. At Nuclein, we offer a fast-paced, exciting, collaborative environment where individual contributions are highly valued as we work to expand the use of our transformative testing technology in the market.

Please visit Nuclein.com for more information about our company's history, technology, and vision.

Position Summary:

The Design Assurance Engineer will lead efforts to ensure the integrity of Nuclein’s product designs, compliance with regulatory requirements, and the delivery of safe and effective medical devices to healthcare professionals and patients. The individual will support quality initiatives, post-market activities, and communications with external bodies.

Responsibilities:

• Serves as the Quality/Regulatory representative on product development teams.
• Leads and assists team members in the creating and maintenance of design deliverables, including design input/outputs, risk management documentation, protocols/reports and other Design & Development deliverables.
• Works directly with the Project Management team to develop IVD development timelines and present reports to executive management.
• Oversees Regulatory Affairs activities including submissions, registrations, and communications with FDA and other associated international regulatory bodies as assigned.
• Coordinates all clinical trial activities, from contracts and material scheduling through final data approval of clinical trial results leading up to product submissions.
• Supports post market activities, such as design changes, surveillance and recalls.
• Evaluates on-going changes for Regulatory impact and provides written authorization.
• Collaborates with external consultants as needed.
• Develops, releases, and maintains procedures related to areas of responsibility.
• Collaborates across the organization to provide guidance and leadership.
• Oversees and approves all Labeling (IFU, UDI, Primary Product Labeling, GHS, Marketing).
• Supports 3rd Party Audits.

 Qualifications:

• Bachelor's degree in a scientific or engineering discipline or related field.
• 3+ years of design assurance engineering and/or regulatory affairs experience in a regulated environment, preferably in the medical device industry.
• 1+ year of experience as a member of a design team.
• Experience communicating technical content with Regulatory bodies, both written and verbal. International experience preferred.
• Regulation Knowledge in CFR 820, 803, 807, 809, 806 & ISO 13485:2016, ISO 14971 required.
• Experience working cross-functionally and managing dynamic priorities.