Design Assurance Engineer

Invent Staffing; United States; On-site; Part time

Job summary

A leading staffing firm is seeking a Design Assurance Engineer to ensure compliance with Quality System standards in electromechanical systems. The role includes managing design assurance activities, conducting risk assessments, and collaborating with cross-functional teams. Candidates should hold a Bachelor's in Engineering and possess over 3 years of experience in regulated industries like medical devices. The salary range is competitive, reflecting industry standards for expertise in quality assurance and design compliance.

Qualifications

• 3+ years in design assurance or quality assurance within regulated industries.
• Experience with GMP, ISO quality systems, and FMEA process.
• Strong collaboration and communication skills.

Responsibilities

• Ensure compliance with GMP and ISO standards in design assurance.
• Manage Design History Files for new products.
• Collaborate cross-functionally to define product requirements.

Skills

Communication

Collaboration

Risk Management

Education

Bachelor’s degree in Engineering

Job description

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This range is provided by Invent Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$55.00/hr - $60.00/hr

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.
• 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.
• 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.

Seniority level

• Seniority level

  Associate

Employment type

• Employment type

  Contract

Job function

• Industries

  Medical Equipment Manufacturing

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