Position: Design Assurance Engineer
Nature of Role: Reporting to the Design Quality Assurance Manager or Director, 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
- 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
- Must be able to work independently and as a member of a cross-functional team, to multi-task and do what it takes to meet high expectations and tight deadlines. Will be working on highly visible projects in high-pressure situations
- Must have strong written & oral communication skills and the ability to communicate appropriately with different engineering teams, Product Management, vendors, partners, and customers
- Must be able to travel occasionally to meet with customers / project teams
- High level of competence in statistical techniques, such as 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 Regulations, ISO 13485 principles
- Experience in Risk Management Activities and a strong understanding of ISO 14971
- Experience in Design Verification, Process Validation, 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
- Capable of risk-based decision making, and communicating decisions articulately
- 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
- 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
- Plans, and leads execution of Risk Management on cross functional product development teams. These items include but are not limited to Risk Management Plans, Preliminary Hazard Analyses, UFMEAs, DFMEAs, PFMEAs, and Risk Management Reports
- Provides Quality insight and leadership on program teams, and helps establish appropriate build quality controls commensurate with use
- Supports device builds and supplier procurement during the design and development process. This includes but is not limited to inspections, supplier quality, and non-conformances.
- Plans, develops, and manages the execution verification testing for products under development
- Initiates, develops, documents, and validates methods for inspection, testing, and evaluation utilizing knowledge in engineering fields such as electrical, or mechanical
- Supports quality engineering and development teams in product/process transfers during pilot and manufacturing builds
- Supports the quality management system and the quality systems team as assigned, including but not limited to maintenance of quality standards, SOP development, returned products, continual improvement initiatives, corrective actions, and audit/audit finding support.
DAVIS Companies partners with the top employers locally and nationally. They choose us because of our reputation for finding high quality talent, fast, but also our experience for evaluating and representing the best candidates in the marketplace. We make every effort to provide updates and feedback to candidates at each stage of the process as we appreciate how stressful looking for a new role can be. Apply today and experience “The DAVIS Difference”.