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Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Senior Device Engineer – Electromechanical Combination Products (Lifecycle Management, Design Control, CAPA) - (JP15315)
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Electromechanical Platform
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/30/26
Pay Rate: $44 - $48.50/hour W2
Notes: Only qualified candidates need apply. On site in Thousand Oaks, CA. 3-5 days onsite depending on business needs. Standard hours
3 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 team
Top Must Have Skills:
Day to Day Responsibilities:
Basic Qualifications:
Preferred Qualifications:
Red Flags:
Interview process:
Location: Thousand Oaks, CA. 91320
Employment Type: Contract
Business Unit: Electromechanical Platform
Duration: 1+ year (with likely extensions and/or conversion to permanent)
Posting Date: 04/30/26
Pay Rate: $44 - $48.50/hour W2
Notes: Only qualified candidates need apply. On site in Thousand Oaks, CA. 3-5 days onsite depending on business needs. Standard hours
3 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 team
Top 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
Regards,
3KC Talent Acquisition Team