Director of Engineering Operations
We are seeking a highly skilled Director of Engineering Operations to lead our verification and validation team.
* Oversee the development and optimization of physical test methods, fixtures, and systems to support product development and changes.
* Author technical reports, work instructions, and validation documentation to ensure compliance with regulatory and quality system requirements.
* Execute and oversee test method validation, design verification, and transfer activities to deliver high-quality products.
* Collaborate with cross-functional teams, suppliers, and partners to achieve verification and validation deliverables.
* Analyze and interpret test data, identifying out-of-spec results and supporting investigations to drive process improvements.
Qualifying Criteria:
* Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field.
* 10+ years of experience in medical devices, pharmaceuticals, or life sciences, with a proven track record of leading technical teams.
* Strong background in developing and qualifying test systems and methods (IQ, OQ, MSA, etc.).
* Hands-on experience with design verification/validation for mechanical or electromechanical medical devices.
* Proficiency in statistical data analysis tools (e.g., Gage R&R, Hypothesis Testing, Tolerance Analysis, Minitab, SAS).
* In-depth knowledge of regulatory standards (FDA 21 CFR Part 820, EU MDR).
* Extensive understanding of risk-based validation approaches.
Key Skills & Attributes:
* Strong leadership and team development abilities.
* Excellent organizational, communication, and problem-solving skills.
* Ability to manage multiple priorities in a fast-paced environment.
* Highly collaborative, with advanced technical and managerial judgment.
About This Role:
This is an exciting opportunity for a seasoned professional to join our engineering team as a Director of Engineering Operations. If you have a passion for leading cross-functional teams and driving process improvements, we encourage you to apply.