Design Assurance Engineer

North American Rescue
US - South Carolina - Greer
January 23, 2025

SUMMARY

The Design Assurance Engineer serves as the quality representative on design core teams for medical devices in the pre-hospital market. This role guides development teams through the Design Control process, ensuring compliance with FDA, ISO, QSR, quality, safety, environmental regulations, and internal procedures. The Design Assurance Engineer also supports quality initiatives, post-market design changes/improvements, and quality surveillance activities.

ESSENTIAL RESPONSIBILITIES

Design Control Guidance: Actively participates on design teams, leveraging experience to guide members through the Design Control process to achieve business, operational, quality, and safety goals for new products.
Design Verification and Validation Activities: Coordinates required design verification and validation testing.
Deliverables Management: Assists team members in creating and maintaining design deliverables (e.g., Design & Development Plans, Inputs/Outputs, Protocols, Matrices) to ensure timely completion and regulatory compliance.
Risk Management: Leads the risk management process for design teams, ensuring comprehensive identification, mitigation, and verification of risks through the creation of risk
Protocol Development: Recommends and develops rationale for protocol structure, including the application of statistical tools.
Cross-Functional Resource: Acts as a resource for design control-related questions and challenges within and across departments.
Audit Support: Provides support during external audits and
Additional Duties: Performs other duties as

AUTHORITY

Role has the authority to approve design and development/design history

ACCOUNTABILITY

Ensure all design and risk files are adequate
Help ensure operational compliance with SOPs
Ensure completion of action steps from inspections, audits, and CAPA

QUALIFICATIONS

Education

Bachelor's degree in engineering, life science, or a related scientific discipline with at least 2 years of experience in quality engineering, product manufacturing, or R&D, or a master's degree with 1 year of relevant experience required

Competency and Skills

Practical experience with design assurance processes, including managing design controls, verification, and validation
Proficiency in quality assurance principles, including risk management (ISO 14971), statistical analysis, and usability (ISO 62366)
Familiarity biocompatibility requirements (ISO 10993), sterility requirements (ISO 11137), and packaging validations (ISO 11607) is preferred
Strong technical writing skills
High-level problem-solving and analytical abilities, including statistical tool
Excellent organizational, management, and multitasking
Strong communication and interpersonal
Attention to detail with a proactive approach to problem-
Proficiency in MS Office

Experience

Appropriate combination of education and experience based on requirements under Education Qualifications

Specific Characteristics

Must be able to pass all background checks

DEMANDS

Time and Availability

Must be able to work a minimum of 40 hours each week, generally from 8am-5pm

Must be able to work extended hours and overtime on normal workdays and/or weekends as needed and demanded by job duties

Travel

Must have transportation to and from headquarters and can travel out of state up to two weeks per year

Physical

The physical demands described here are representative of those that must be met by a typical office employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Frequently required to hear and talk
Use of hands for keyboard usage
Frequent sitting, standing and walking
Occasional reaching with hands and arms, stooping, kneeling, and lifting and/or moving up to 30lbs

Environment

Must be able to work in a moderately loud work environment

DISCLAIMERSAAP/EEO Statement

North American Rescue provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law. Further, the company takes affirmative action to ensure that applicants are employed and employees are treated during employment without regard to any of these characteristics. Discrimination of any type will not be tolerated.

Read the full job description and apply online on the recuiter's web-site

Design Assurance Engineer

Design Assurance Engineer

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