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Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315)

3 Key Consulting
  • Thousand Oaks, California
  • $44–$48.50 Per Hour
  • Autofill and Review
30+ days ago

Job Description

Job Title:   Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315)Location: Thousand Oaks, CA. 91320Employment Type: ContractBusiness Unit: Electromechanical PlatformDuration: 1+ year (with likely extensions and/or conversion to permanent)Posting Date: 04/30/26Pay Rate: $44 - $48.50/hour W2Notes: Only qualified candidates need apply. On site in Thousand Oaks, CA. 3-5 days onsite depending on business needs.  Standard hours3 Key Consulting is hiring an Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) 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.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.Why is the Position Open?Supplement additional workload on teamTop Must Have Skills:
  • Lifecycle Management Experience with electromechanical platforms
  • Root Cause Analysis and Technical Problem Solving
  • Proven success in cross-functional engagement and being a team player
  • Nice to have: Early device development experience
Day 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 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.
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 experience
Preferred 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 teams
    • Excellent written and verbal communication skills
    • Must 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 Oaks
  • Low motivation/engagement at prospect of working with medical device and/or combination products
  • Poor written and verbal communication
  • Candidates looking to be in a management role. Too much experience 10+ YOE.
Interview process:
  • 1:1 with hiring manager
  • 1:2 or 1:3 with prospective team members
  • Remote video Interviews

Numbers & Facts

LocationThousand Oaks, California
Salary$44–$48.50 Per Hour

Skills

  • Biomedicineunmatched
  • Biotech and Pharmaceuticalunmatched
  • Change Controlunmatched
  • Change Managementunmatched
  • Code of Federal Regulationsunmatched
  • Communication Skillsunmatched
  • Consultingunmatched
  • Continuous Improvementunmatched
  • Corrective and Preventative Action (CAPA) Systemsunmatched
  • Cross-Functionalunmatched
  • Data Analysisunmatched
  • Design Verificationunmatched
  • Documentationunmatched
  • Drug Delivery Devicesunmatched
  • Electricityunmatched
  • Electromechanical Engineeringunmatched
  • Electromechanical Systemsunmatched
  • Electromechanicsunmatched
  • Failure Analysisunmatched
  • High School Diplomaunmatched
  • Human Factorsunmatched
  • ISO (International Organization for Standardization)unmatched
  • Injectionsunmatched
  • Laboratory Testingunmatched
  • Logisticsunmatched
  • Maintain Complianceunmatched
  • Manufacturing Requirementsunmatched
  • Mechanical Engineeringunmatched
  • Medical Equipmentunmatched
  • Minitabunmatched
  • Presentation/Verbal Skillsunmatched
  • Problem Solving Skillsunmatched
  • Process Managementunmatched
  • Product Developmentunmatched
  • Product Engineeringunmatched
  • Product Lifecycle Managementunmatched
  • Product Reviewsunmatched
  • Product Supportunmatched
  • Quality Managementunmatched
  • Quality System Requirements (QSR)unmatched
  • Regulationsunmatched
  • Research & Development (R&D)unmatched
  • Risk Managementunmatched
  • Root Cause Analysisunmatched
  • Statistical Analysis System (SAS)unmatched
  • Statistics Softwareunmatched
  • Systems Administration/Managementunmatched
  • Team Playerunmatched
  • Technical Writingunmatched
  • Technical/Engineering Designunmatched
  • Test Designunmatched
  • Testingunmatched
  • Time Managementunmatched
  • Traceabilityunmatched
  • Writing Skillsunmatched

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