What are the responsibilities and job description for the Mechanical Engineer position at ACL Digital?
Title: Senior Engineer
Location: Thousand Oaks CA
Duration: 12 Months
Description
USTO - 3-5 days onsite depending on business needs - Standard hours
Ideal candidate: Seeking candidates with experience in combination products, electromechanical systems, or medical devices, a background in pharma, and hands-on expertise in design control and testing.
contract electromechanical combination product Sr. Engineer. The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Responsibilities:
• Provide design verification support for combination products, ensuring compliance with Quality System Requirements, Design Control (21 CFR 820.30), and ISO 13485.
• Lead and execute on-site testing and verification activities for electromechanical delivery systems and related platforms.
• Develop, review, and execute test protocols, reports, and technical documentation in accordance with design control and regulatory expectations.
• Perform data verification, analysis, and traceability reviews to ensure product performance meets user needs and design inputs.
• Manage materials and maintain traceability of material inventory at Thousand Oaks to support various design control activities. Additionally, support supply of the materials as required to internal and external sites.
• Partner cross-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
• Support control plans, requirements management, and risk management activities (DFMEA, PFMEA) as part of design verification strategy.
• Contribute to continuous improvement of test methods, design verification processes, and documentation practices in line with
device development framework.
• Manage change assessments driven by internal and external changes during the life cycle of the combination product
• Participate in and support cross-functional design reviews for combination product development.
