Regulatory Affairs Engineer Jobs

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1d ago

Sr. Design Engineer

Astura Medical Irving, TX

Irving, TX

1d ago

Full time Senior Design Design Control

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Job Description

Astura Medical is seeking a Sr. Design Engineer to lead the design, development, verification, and validation of spinal hardware within the R&D group. This onsite role in Irving, Texas, emphasizes cross-functional collaboration and strict regulatory adherence as you guide products from concept through launch and ongoing improvements. The ideal candidate will bring a solid foundation in mechanical or biomedical engineering and a track record of delivering medical device solutions that meet market needs and compliance requirements.

Responsibilities

Lead assigned product development and sustaining projects from inception through lifecycle management.
Collaborate with cross-functional teams, including R&D, Quality Assurance, Manufacturing, and Regulatory Affairs, to meet project goals and timelines.
Drive the design, development, verification, and validation of new products, ensuring alignment with market needs and regulatory expectations.
Develop detailed mechanical component and assembly CAD models.
Produce comprehensive product drawings and component specifications.
Oversee design transfer activities from R&D to manufacturing, optimizing processes for scalability.
Prioritize and manage sustaining engineering efforts for existing products, pursuing design improvements and manufacturing optimizations.
Implement corrective actions and continuous improvement initiatives based on post-market feedback and quality data.
Ensure compliance with FDA regulations for medical devices, including 21 CFR Part 820.
Collaborate with Regulatory Affairs to support regulatory submissions.
Evaluate and recommend technologies, tools, and resources needed for product development and sustaining activities.

Requirements

Minimum B.S. degree in Mechanical Engineering, Biomedical Engineering, or a related field.
At least 5 years of engineering experience within the medical device industry.
Strong background in medical device product development, including design, testing, and manufacturing processes.
Knowledge of materials selection, manufacturing processes (e.g., machining, casting), and product lifecycle management.
Experience with analytical methods such as FEA, numerical modeling, and risk analysis.
Experience with contract manufacturers and maintaining productive working relationships.
Experience with implantable medical devices or surgical instrumentation.
Familiarity with design for manufacturability (DFM) and design for assembly (DFA) principles.
Excellent organizational and communication skills, with the ability to manage multiple projects simultaneously.
A hands-on, driven work ethic and a proactive approach to problem solving.

Authorization to Work in the U.S.

Candidates must be legally authorized to work in the United States without sponsorship now or in the future. Astura Medical is not currently sponsoring visas, including H-1B, TN, or EAD, and we are not accepting visa transfers.

Physical Requirements

This role is largely sedentary, involving extended periods at a desk and computer work. It may require occasional lifting of files, reaching, bending, and standing as needed.

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