Quality Design Engineer 2

Hologic•Newark, DE

2d•$78,000 - $122,000

About The Position

The Quality Design Engineer II is responsible for executing design changes, product enhancements, and quality projects. This role ensures strategic and quality goals are achieved through technical design investigation, root cause analysis, and compliance with regulatory standards. The Quality Design Engineer drives process and product improvements by analyzing post-market data, customer feedback, and field investigations, and works collaboratively across departments to ensure products remain safe, compliant, and meet customer expectations.

Requirements

Bachelor’s Degree in engineering, scientific discipline, or related field (BSME, BSEE, etc.)
At least 3 years experience, in a medical device process and/or product development environment.
Experience with FDA Quality Systems Regulation, especially Design Control requirements, ISO 13485, ISO 14971 (Risk Management), and Medical Devices Directive.
Ability to work effectively and collaboratively on project teams
Strong knowledge of root cause failure analysis, statistical methods, and design of experiments.
Competency in statistical analysis and tools (MiniTab preferred).
Proficiency with CAD tools, per engineering discipline.
Strong knowledge of Good Laboratory Practices and QSR (Quality Systems Regulations).
Knowledge of manufacturing processes (e.g., machining, injection molding, common joining methods, rapid prototyping).
Proficient with tolerance stack ups, DFM, and GD&T.
Technical writing ability, including authoring protocols, reports, requirements, and risk documentation.
Action and detail oriented with an aptitude for technical learning; fast and accurate communication to team members and management.
Must follow all applicable FDA regulations and ISO requirements.

Responsibilities

Responsible for design changes, product enhancements, and quality projects, including related testing, assuring product inputs are clearly identified, and design verification and validation activities are appropriate and compliant to confirm input requirements are met.
Manage product design changes related to quality projects by troubleshooting product, process, and component issues related to complaints and customer experience.
Develop solutions to design, process, and quality issues through engineering principles, analysis, and empirical methods, identifying possible root causes as part of verification and validation activities.
Work collaboratively with R&D, PQE, and RA to coordinate design elements of risk management files to ensure compliance with applicable standards and internal policies.
Support PMQA in performing complaint investigations and root cause analysis for product returns.
Support the PQE team as needed for testing or documentation required for investigations and corrective actions or product/process improvements.
Design and prototype fixtures and establish methods to support design verification/validation activities and testing.
Develop test methods, protocols, and reports for design verification, validation, and process validation activities related to quality projects.
Execute protocols and laboratory notebook studies, maintaining accurate records of testing strategies and outcomes.
Support completion of Design History File documentation per FDA and other compliance requirements.
Coordinate work with outside vendors and internal personnel, including material procurement and testing.
Interact with internal and external customers to resolve quality issues related to complaints and/or customer experience.
Prepare complete project documents, including engineering reports and verification/validation documentation; review documents for conformity and quality assurance.
Apply broad knowledge of risk management tools to identify, assess, and mitigate risks throughout the product lifecycle.