Design Assurance Engineer

Summary:

Design, implement and review test plans and protocols to ensure that medical device/equipment products meet all quality standards. Oversee product quality throughout the entire product design realization process. Work closely with research and development to support new product development and improve product design. Investigate non-conformances and suggest changes as necessary. Work under general supervision with latitude for independent judgment. Required to consult with senior peers on certain projects as required.

Responsibilities of this Role:

• Support and monitor new product development project needs in design controls for adherence to the internal quality management system and all ISO, FDA, and QSR regulations.
• Drive and ensure proper design controls are appropriate during design reviews.
• Manage input to operations regarding quality issues such as process improvements and risk (DFMEA & PFMEA) updates.
• Manages the pre- & post-production Design Assurance / Quality Engineering activities as they relate to product lifecycle development
• Review and approve test verification / validation protocols and reports. Work with Supplier Quality and Supply Chain groups to ensure product suppliers are effectively developed.
• Verify configuration management and Risk Analysis records are properly addressed, accurate, and maintained.
• Provide expertise in the interpretation of regulatory requirements, such as those from the FDA, etc.
• Ensure design changes are processed in accordance with current change-control requirements.
• Manage and complete assigned tasks on schedule and identify and propose resolution for issues that may affect the timeline for remediation activities.
• Provide quality engineering support for investigations as required.
• Coordinate resolution of potential quality assurance deficiencies discovered during the product realization process.
• Support CAPA investigations, reviews, approvals, and/or CAPA plan implementations as required.

Other Duties:

Please note this job description is designed to cover a majority (but not all) of the activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without advance notice.

Required Skills and Qualifications:

• Bachelor's degree with a minimum of 5-7 years of experience in medical device design controls.
• Experience in startup organization is a plus.
• Demonstrated and impactful experience in product and process validation, software validation (device & quality system support), test method validation, Statistics, Risk Management Tools and Process Control & Monitoring (SPC).
• Ability to interpret trends and data, translating the information into actions, outcomes and improvements
• Excellent documentation skills, with a solid process orientation and effective attention to detail
• Strong verbal and written communication skills a must.
• Strong interpersonal skills with the aptitude to be a team player; setting a professional tone and establishing a cooperative partnership within the department and other areas of the company
• Independent critical thinker, with the aptitude to work autonomously
• Proficiency in all MS Office products
• Quality engineering certification (ASQ CQE or CQA) desired
• Knowledge of lean six sigma manufacturing processes

Supervisory Responsibility:

This position does not have supervisory responsibilities.

Work Environment:

This job works Hybrid (remotely / HQ)

EEO Statement:

EOE/Vet/Disabled