Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA)3 Key Consulting is hiring a Senior Device Engineer – Electromechanical Combination Products for a consulting engagement with our direct client, a leading global biopharmaceutical company.Job Description: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.Why is the Position Open?Supplement additional workload on teamTop Must Have Skills:Lifecycle Management Experience with electromechanical platformsRoot Cause Analysis and Technical Problem SolvingProven success in cross-functional engagement and being a team playerNice to have: Early device development experienceDay to Day 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 productParticipate 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.Basic Qualifications: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 experiencePreferred Qualifications: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)Smartsheets proficiency is a plus.Ability to work independently and dynamically across functional teamsExcellent written and verbal communication skillsMust be capable of working on multiple projects in a deadline driven environment.The position is designed for candidates at a mid-career stage, with scope and responsibilities aligned to that level of experience.Red Flags:Unable to be consistently on-site in Thousand OaksLow motivation/engagement at prospect of working with medical device and/or combination productsPoor written and verbal communicationCandidates looking to be in a management role. Too much experience 10+ YOE.Interview Process:1:1 with hiring manager1:2 or 1:3 with prospective team membersRemote video Interviews
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