"Alerted.org

Duration: 12 months contract

**Shift:** Regular Working Hours

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.

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 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, 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 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.

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.

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

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 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).

About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com .

"US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran"