Posted: 11/06/2025 Job Number: 41524

Job Description

Engineer Senior

Top 3 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

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
too entry level or too experienced - hands on work is required and a strong eagerness to grow is required.

Summary:

Our company is seeking a contract electromechanical combination product Sr. Engineer. The Sr. Engineer will lead and support design development and lifecycle management-related activities for commercialized drug delivery devices and devices under development.

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 in 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, Human Factors, 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 our 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

Masters degree and 2 years of experience

Bachelors degree and 4 years of experience

Associates degree and 8 years of experience

High school diploma / GED and 10 years of experience

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.

Pay range is $38 - $43 per hour with full benefits available, including paid time off, medical/dental/vision/life insurance, 401K, parental leave, and more. Our compensation reflects the cost of labor across several US geographic markets. Pay is based on several factors including market location and may vary depending on job-related knowledge, skills, and experience.

THE PROMISES WE MAKE:

At Crystal Equation, we empower people and advance technology initiatives by building trust. Your recruiter will prep you for the interview, obtain feedback, guide you through any necessary paperwork and provide everything you need for a successful start. We will serve to empower you along the way and provide the path for your professional journey.

For more information regarding our Privacy Policy, please visit crystalequation.com/privacy.

Meet Your Recruiter

Krista McIlwaine

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About Thousand Oaks, CA

Ready to take your career to the next level in the vibrant city of Thousand Oaks, California? Nestled in the heart of Ventura County, this bustling city offers a perfect blend of suburban charm and urban amenities. With a strong job market, top-notch schools, and breathtaking views of the Santa Monica Mountains, Thousand Oaks is an ideal location for professionals seeking growth and fulfillment. Explore job opportunities near iconic sites like the Gardens of the World, catch a show at the Fred Kavli Theatre, or indulge in the local culinary scene featuring dishes from around the world. Join this dynamic community and unlock your potential in Thousand Oaks! Start your job search now to find your perfect fit in this captivating city.