Overview
Design Assurance Engineer Jobs in United States at Invent Staffing
Title: Design Assurance Engineer
Company: Invent Staffing
Location: United States
Key Responsibilities:
Quality System Compliance:
Ensure adherence to the company’s established Quality System, GMP, and ISO standards.
Lead ongoing improvements to the quality system procedures and ensure compliance with applicable regulations.
Design Assurance for Electromechanical Systems:
Lead design assurance activities in support of development for electromechanical systems incorporating microcontroller technology, customized or off-the-shelf PCBs, and software applications.
Ensure design processes comply with GMP/ISO quality system practices and guidelines.
Design History Files Management:
Manage and maintain Design History Files (DHFs) for new products.
Ensure the DHF is complete and compliant with regulatory requirements.
Cross-Functional Collaboration:
Partner with Engineering, Marketing, Manufacturing, and Regulatory teams to define measurable and valid product requirements.
Support new product start-ups by establishing testing checkpoints for new products and processes.
Test Planning & Execution:
Develop and document test plans, protocols, procedures, and reports.
Perform tests in accordance with protocol requirements and communicate results to stakeholders.
Aide in the definition and specification of test equipment required to accomplish quality objectives.
Risk Management & Analysis:
Lead risk management activities, including FMEA (Failure Mode and Effect Analysis), to assess product risk and design reliability.
Devise and document design verification and validation plans based on performance specifications and risk analysis.
Compliance & Performance Monitoring:
Analyze and communicate conformance to product specifications, regulatory standards, and quality requirements.
Conduct technical and statistical investigations to ensure compliance with specifications and optimize design performance.
Support In Vitro and Animal Testing:
Assist in the completion of in vitro testing and applicable animal studies to support product validation.
Supplier Quality Assurance:
Define supplier quality specifications, sampling plans, and vendor qualification criteria.
Assist in the testing and specification of sterilization methods for products.
Continuous Improvement:
Lead system and product continuous improvement teams to drive enhancements in product quality and manufacturing efficiency.
Regulatory and Engineering Change Support:
Review Engineering Change Orders (ECOs) and ensure changes align with design assurance and quality standards.
Assist with regulatory submissions and ensure ongoing product compliance with relevant standards and regulations.
Other Duties:
Perform other duties and responsibilities as assigned by senior management to support the company’s quality assurance and product development objectives.
Required Qualifications:
Bachelor’s degree in Engineering (Mechanical, Electrical, Biomedical, or related field).
3+ years of experience in design assurance, quality assurance, or related fields, particularly within regulated industries (medical devices, electromechanical systems).
Experience with GMP and ISO quality systems, including documentation and testing.
Strong understanding of risk management processes (e.g., FMEA).
Experience in design verification and validation of electromechanical systems, including microcontroller-based technology, PCBs, and software applications.
Ability to work collaboratively in cross-functional teams and manage multiple tasks and projects.
Strong communication skills for writing protocols, test plans, reports, and for interacting with stakeholders.
