New Product Introduction: Quality & Validation Engineer

Merrimack Manufacturing; Manchester (NH); On-site; USD 80,000 - 110,000; Full time

Job summary

Merrimack Manufacturing is seeking a qualified engineer to support design transfer and quality operations in a fast-paced medical device environment. You will generate and maintain control plans, risk management files, validation protocols, and QMS documentation to support initial qualification and launch of commercial production.

You will lead improvement projects to boost efficiency and ensure compliance across the site, including MRB activities and nonconformance investigations with

Qualifications

• Experience with regulatory standards (CFR Part 820, ISO 13485) and medical device manufacturing.
• Knowledge of IQ/OQ/PQ, calibration practices, and measurement systems analysis.

Responsibilities

• Evaluate new products and processes for regulatory compliance throughout NPI.
• Develop/update User Requirements, CTQs, and design documentation.
• Lead validation protocol generation, execution, and reporting to meet timelines.

Skills

CFR Part 820

ISO 13485

Lean/Six Sigma

IQ/OQ/PQ

Design Transfer

Tolerance stack-up

Project Management

Software Validation

GxP/Regulatory

Education

B.A./B.S. in technical field

Job description

Merrimack Manufacturing is seeking a qualified engineer to support design transfer and quality operations in a fast-paced medical device environment. You will generate and maintain control plans, risk management files, validation protocols, and QMS documentation to support initial qualification and launch of commercial production.

You will lead improvement projects to boost efficiency and ensure compliance across the site, including MRB activities and nonconformance investigations with