Electromechanical Medical Device Design Engineer

ACL Digital; Thousand Oaks (CA); On-site; USD 90,000 - 130,000; Full time

Job summary

ACL Digital seeks an experienced Device Engineer to support electromechanical combination products within drug delivery platforms. You will participate in design development and lifecycle management activities for commercialized devices and those under development.

The role emphasizes design verification, testing, and collaboration across R&D, Quality, Regulatory, and Manufacturing to ensure compliance with 21 CFR 820.30 and ISO 13485.

Qualifications

• Master's or Bachelor's Degree in Engineering, 3–5 years in highly regulated environment (medical device, biopharma, combination product).
• Experience with electromechanical systems, injection devices, medical devices or delivery platforms preferred.
• Lifecycle management, data analysis, and protocol/report generation under design control.

Responsibilities

• Provide ongoing lifecycle management (LCM) support for electromechanical combination products, including post-market activities, design improvements, and cross-functional issue resolution to ensure product reliability and compliance.
• Lead complaint investigations by performing detailed failure analysis, identifying root causes, and developing data-driven action plans in collaboration with quality, manufacturing, and regulatory teams.
• Drive and manage quality system processes including CAPAs, deviations, and change controls, ensuring timely closure, robust documentation, and alignment with regulatory and internal requirements.
• Collaborate closely with external suppliers to support LCM activities, including issue resolution, component updates, root cause analysis, CAPAs and continuous improvement initiatives to maintain supply continuity and product performance.
• 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.
• 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.
• Partner cross-functional with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.

Skills

Design control

Lifecycle management

Root cause analysis

Data analysis

Cross-functional collaboration

Quality system knowledge

Verbal and written communication

Project management

Problem solving

Independent work

Education

Bachelor's or Master's in Mechanical/Biomedical/Electrical Engineering

Tools

Minitab

Smartsheet

Job description

ACL Digital seeks an experienced Device Engineer to support electromechanical combination products within drug delivery platforms. You will participate in design development and lifecycle management activities for commercialized devices and those under development.

The role emphasizes design verification, testing, and collaboration across R&D, Quality, Regulatory, and Manufacturing to ensure compliance with 21 CFR 820.30 and ISO 13485.