Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15626)

3 Key Consulting•Thousand Oaks, CA

9d•Hybrid

About The Position

Our client is seeking a contract electromechanical combination product Device Engineer. The Device Engineer will participate in design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

Requirements

Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience OR Associates degree and 8 years of experience OR High school diploma / GED and 10 years of experience
Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 3-5 years (or 2 years with Masters) of professional experience in highly regulated environment (strong preference for medical device, biopharma and/or combination product experience).
Experience with electromechanical systems, injection devices, medical devices or delivery platforms preferred.
Demonstrated expertise in lifecycle management, data analysis, and protocol/report generation under design control.
Strong understanding of materials coordination, supplier interaction, and lab testing logistics.
Proven ability to work in cross-functional project teams, communicate technical results clearly, and lead execution to meet program milestones.
Working proficiency in statistical analysis software (Minitab)
Excellent written and verbal communication skills
Must be capable of working on multiple projects in a deadline driven environment.

Nice To Haves

Early device development experience
Smartsheet proficiency is a plus.
Ability to work independently and dynamically across functional teams

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-functionally with R&D, Human Factors, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.