Sr. Design Quality Engineer (Medical Devices)

Location: Memphis, Tennessee, United States of America. Relocation assistance is not available.

Salary: $115,000–$147,600 per year

Company

hirify.global develops medical devices and related healthcare technologies.

What you will do

• Develop and evaluate medical device designs for manufacturability, reliability, performance, and cost.
• Create design test methodologies and specifications to verify product functionality.
• Apply DMAIC, Design for Reliability and Manufacturability, Lean Six Sigma, statistical analysis, DOE, SPC, and process capability methods.
• Evaluate product and process risks using FMEA and ISO 14971, and troubleshoot production issues with A3, PDCA, 5 Whys, Ishikawa, and RCA techniques.
• Execute IQ, OQ, and PQ process qualification activities and support CAPA implementation.
• Develop and maintain PSURs, CERs, technical documentation, PPAP documentation, control plans, process flows, and material requirements for transfer projects.

Requirements

• Master’s degree in Mechanical, Industrial, Biomedical, or a related engineering field.
• At least two years of experience as a quality, product, or validation engineer.
• At least two years of experience with DMAIC, Minitab, DOE, SPC, Variable Gage R&R, ANOVA, t-tests, regression analysis, process capability, and confidence and tolerance interval analysis.
• At least two years of experience with FMEA, ISO 14971, QMS, CTQ identification, FDA 21 CFR Part 820, ISO 13485, and Good Documentation Practices.
• At least two years of experience with IQ/OQ/PQ, CAPA, RCA, PSURs, CERs, EU MDR technical documentation, PPAP, control plans, process flows, and material requirements.

Culture & Benefits

• Health, dental, and vision insurance for eligible regular employees working 20 or more hours per week.
• Health Savings Account, Healthcare Flexible Spending Account, life insurance, long-term disability coverage, and dependent daycare spending account.
• Tuition assistance or reimbursement and a global well-being program.
• Incentive plans, 401(k) with employer contribution and match, paid time off, and paid holidays.
• Employee Stock Purchase Plan, Employee Assistance Program, and retirement plan benefits for eligible employees.