Engineering Manager (Medical Devices)

Location: Danvers, Massachusetts, United States. Relocation assistance is not available.

Salary: $178,000–$213,000 per year

Company

hirify.global develops medical device products and operates regulated medical device manufacturing functions.

What you will do

• Plan, direct, and implement the design and development of new medical device products.
• Manage technical quality assurance and control systems for extrusion and assembly manufacturing.
• Select, develop, and evaluate personnel to ensure efficient function operation.
• Manage risk assessments, including PHA, PFMEA, and ISO 14971 medical device risk management.
• Lead non-conformance management, complaints, CAPA, process improvement, and inspection optimization projects.
• Manage product validation activities, including IQ, OQ, and PQ, and use DOE and Minitab for process development and statistical analysis.

Requirements

• Master’s degree in Mechanical, Industrial, Biomedical, or a related engineering field plus 3 years of relevant experience; or bachelor’s degree plus 5 years of relevant experience.
• At least 3 years of experience in quality engineering for medical devices.
• At least 3 years of experience with extrusion and assembly manufacturing, process validation, and quality systems.
• Experience with 21 CFR Part 820, ISO 13485, EU MDR, SOTA, GMP, PHA, PFMEA, and ISO 14971.
• Experience with non-conformances, CAPA, DMAIC, RCA, 5 Whys, Fishbone, cause mapping, DOE, and process development.
• Experience with IQ/OQ/PQ validation and Minitab statistical analysis software.

Culture & Benefits

• Regular employees working 20 or more hours per week may receive health, dental, vision, HSA, FSA, life insurance, long-term disability, dependent daycare, and tuition assistance benefits.
• Regular employees may receive incentive plans, a 401(k) plan with employer contribution and match, paid time off, paid holidays, and short-term disability.
• Additional programs include an Employee Stock Purchase Plan, Employee Assistance Program, and retirement plan benefits.