Design Assurance Engineer
Position: Design Assurance Engineer
Nature of Role: Reporting to the Director of Quality Services, this ‘go-to’ resource stays abreast of current quality and regulatory trends and ensures the successful integration of quality assurance and regulatory compliance, working across multiple teams and medical device/equipment categories.
- Plans, executes or directs activities concerned with development, application, and maintenance of quality standards. Reports results to marketing, manufacturing, process engineering, and product design groups
- Develops and initiates standards and methods for inspection, testing, and evaluation, utilizing knowledge in engineering fields such as electrical, or mechanical
- Establishes programs to evaluate analytical testing, equipment, facilities, precision measurements, accuracy measurements, and performance testing
- Lead or assist in quality evaluation of returned products and support RMA program
- Lead, participate in, or coordinate Internal Corrective Action initiatives
- Participates in the technical review of design input specifications and design documentation for new medical devices
- Participates in the development of system specifications
- Plans, develops, and executes verification testing for products under development
- Performs internal quality and design control audits
- Performs product and process risk assessment activities, including hazard analysis and design/process failure modes & effects analysis (DFMEA/PFMEA)
- Takes an active role to ensure products meet corporate, industry, and regulatory standards
- Assists management in implementing and maintaining a quality system that is compliant with ISO 13485 and FDA quality system regulation requirements
- Develops, documents, and validates inspection and test methods to support design control, in-process inspection, and final inspection activities
- Completes component part qualification activities including first articles, cap studies, gage R&R, and implementation of SPC requirements
- Supports product/process transfers during pilot and manufacturing builds
- Bachelor’s degree in a scientific or engineering field is required
- Experience in a new product development quality engineering role in the medical, electronics packaging, high reliability, or a related industry with manufacturing & assembly processes
- Strong written and verbal communication skills are required, including proficiency with standard office productivity suite and data analysis software
- High level of competence in statistical techniques, including sampling plans, design of experiments, correlation and regression, analysis of variance, probability, measurement system analyses, gage repeatability and reproducibility, etc.
- Experience with design review and design control
- A working understanding of FDA Quality System regulations, EU Active Implantable & Medical Device Directives, ISO 13485 principles
- Experience in Risk Management Activities and a strong understanding of ISO 14971
- Experience in Design Verification, Process Validation, and developing user needs and design inputs
Our fast-paced environment demands the ability to manage multiple projects within various disciplines and deadlines. High-energy, self-starters with the following qualities:
- Successful communication skills, business acumen and assertive decision-making ability
- Flexibility to multi-task and perform a wide range of activities
- Excellent computer skills, including MS Office proficiency, Minitab experience preferred
- Self-motivated and capable of working with minimal supervision
Send resume to: HR@ximedica.com.
EQUAL OPPORTUNITY EMPLOYERXimedica provides equal employment opportunities to all qualified applicants and employees regardless of race, color, religion, gender, age, national origin, sexual orientation, veteran status, disability that can be reasonably accommodated, or any other basis prohibited by federal, state, or local law.