Engineer Senior, Electromechanical, Biotech Medical Device - Hybrid (JP14738)

Job 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/hr 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 View email address on click.appcast.io. Ifyou 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 You are also welcome to share this opportunity with anyone you think might be interested in applying for this role. #J-18808-Ljbffr 3key Consulting, Inc.