As a seasoned R&D leader, we are seeking an Associate Director to oversee Verification & Validation (V&V) activities in support of new product development (NPI) and lifecycle management of medical devices.
This position is highly suitable for those with a strong background in developing and qualifying test systems and methods, as well as hands-on experience with design verification/validation for mechanical or electromechanical medical devices.
The successful candidate will lead and mentor a small team of V&V engineers, driving all verification and validation activities. They will develop and optimize physical test methods, fixtures, and systems to support product development and changes.
Key Responsibilities:
* Lead and mentor a small team of V&V engineers, driving all verification and validation activities.
* Develop and optimize physical test methods, fixtures, and systems to support product development and changes.
* Author technical reports, work instructions, and validation documentation.
* Execute and oversee test method validation (TMV), design verification, and transfer activities.
* Write and manage verification protocols to ensure compliance with regulatory and quality system requirements.
* Perform functional and performance testing of medical devices.
* Collaborate with cross-functional teams, suppliers, and partners to achieve V&V deliverables.
* Analyze and interpret test data, identifying out-of-spec results and supporting investigations.
* Ensure test equipment and methods are validated in line with business and regulatory standards.
Qualifying Criteria:
* Bachelor's degree in Mechanical, Biomedical, Systems Engineering, or related field.
* 10+ years of experience in medical devices, pharmaceuticals, or life sciences.
* Proven experience 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.
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.
* Self-driven, detail-oriented, and results-focused.