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Engineer Senior, Electromechanical, Biotech Medical Device - Hybrid (JP14738)
Thousand Oaks, CA · Biotech/PharmaceuticalJob Title: Engineer Senior, Electromechanical, Biotech Medical Device - Hybrid (JP14738)
Location: Thousand Oaks, Ca. (3-5 days onsite)
Business Unit: Electromechanical Platform
Employment Type: Contract
Duration: 1 years with likely extension or conversion to perm
Rate: $42-52/hours W2 with benefits
Posting Date: 11/06/2025
Target Start Date: 01/05/2026
3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
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
Job Description:
The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Preferred Qualifications:
Top Must Have Skill Sets:
Day to Day Responsibilities:
Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience.
Red Flags:
Interview Process:
1:1 with hiring manager - Virtual
1:3 (or 1:2) with prospective team members - Virtual
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Location: Thousand Oaks, Ca. (3-5 days onsite)
Business Unit: Electromechanical Platform
Employment Type: Contract
Duration: 1 years with likely extension or conversion to perm
Rate: $42-52/hours W2 with benefits
Posting Date: 11/06/2025
Target Start Date: 01/05/2026
3 Key Consulting is hiring! We are recruiting a Senior Engineer for a consulting engagement with our direct client, a leading global biotechnology company.
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
Job Description:
The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.
Preferred Qualifications:
- Master’s or Bachelor’s Degree in Engineering Discipline (Mechanical, Biomedical, Electrical) with 5-7 years (or 3-5 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, or delivery platforms preferred.
- Demonstrated expertise in design verification testing, 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
- Ability to work on-site in Thousand Oaks full-time (3-5 days/wk).
- Must be capable of working on multiple projects in a deadline driven environment.
Top Must Have Skill Sets:
- Expertise in design control and quality systems (21 CFR 820.30, ISO 13485) with proven ability to plan, execute, and document design verification and validation for combination products.
- Hands-on capability in testing electromechanical systems, including data collection, statistical analysis, and performance evaluation.
- Proven ability to partner effectively with R&D, Quality, Regulatory, and Manufacturing teams.
- Nice to have: Minitab, Smartsheet, and supplier interaction experience
Day to Day Responsibilities:
- 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.
- Manage materials and maintain traceability of material inventory at Thousand Oaks to support various design control activities. Additionally, support supply of the materials as required to internal and external sites.
- Partner cross-functionally with R&D, Quality, Regulatory, and Manufacturing teams to drive design robustness, risk mitigation, and design transfer readiness.
- Support control plans, requirements management, and risk management activities (DFMEA, PFMEA) as part of design verification strategy.
- Contribute to continuous improvement of test methods, design verification processes, and documentation practices in line with Company’s device development framework.
- 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.
- Ability to work on-site in Thousand Oaks full-time (3-5 days/wk).
Basic Qualifications:
Doctorate degree OR Masters degree and 2 years of experience OR Bachelors degree and 4 years of experience.
Red Flags:
- Lack of experience in hands-on testing in laboratory environments
- 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
- Entry level or too experienced - hands on work is required and a strong eagerness to grow is required.
Interview Process:
1:1 with hiring manager - Virtual
1:3 (or 1:2) with prospective team members - Virtual
We invite qualified candidates to send your resume to recruiting@3keyconsulting.com. If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com/careers. You are also welcome to share this opportunity with anyone you think might be interested in applying for this role.
Regards,
3KC Talent Acquisition Team