Usability Engineer
We are looking for an Advanced Quality Engineer to join our Medical Device team to support an M&A project!
Key areas of responsibility for integration
Lead risk management and usability activities for remediation of existing legacy risk and usability documentation to company documentation and forms.
Ensure quality assurance documentation to support integration activities and regulatory submissions.
Partner with cross-functional project teams to support product integration activities.
Evaluate overall residual risk for products and present final risk/benefit justification to executive leadership.
Identified risks associated with the product use (usability)
Track the design, documentation, and manufacturing process mitigation activities for all risks.
Partner with cross-functional project teams to confirm design verification and validation test requirements that ensure appropriate objective evidence is available to support the acceptance criteria.
Analyze market data (clinical and Post-Market) for risk estimation and address concerns.
Education/ work experience
BS in a science, engineering or related discipline.
MS, CQE, or CRE preferred.
Six Sigma Green or Black belt preferred.
Minimum of 5 years experience preferred.
Knowledge/ competencies
Experience with medical device product development lifecycle, including risk management, usability, and design/process verification and validation.
Demonstrated applied knowledge of Advanced Quality tools such as Failure Modes Effect Analysis (FMEA), GD&T, Root Cause Analysis, and Mistake Proofing/Poke Yoke.
Demonstrated ability to read and interpret CAD drawings.
Experience in interacting with regulatory agencies (FDA, MoH, TUV, etc.) required.
Thorough knowledge and understanding of US and International Medical Device Regulations.
Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).
Must possess strong project management skills as well as have the ability to manage multiple tasks simultaneously.
Job Types: Full-time, Contract
Pay: $100,000.00 - $110,000.00 per year
Benefits:
401(k)
Dental insurance
Employee discount
Health insurance
Health savings account
Paid time off
Referral program
Vision insurance
Compensation Package:
Hourly pay
Schedule:
8 hour shift
Monday to Friday
Weekends as needed
Education:
Master's (Preferred)
Experience:
Medical Device: 5 years (Required)
UX: 5 years (Required)
FMEA: 5 years (Required)
GD&T: 5 years (Required)
Risk Management: 5 years (Required)
Product Development Lifecycle: 5 years (Required)
Advanced Quality Engineering: 5 years (Required)
Formative and Summative: 5 years (Required)
IEC 62366: 5 years (Required)
Work Location: Remote