Job Description
Target PR Range : 37-47 / hr
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 productParticipate 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 teamsExcellent written and verbal communication skillsAbility 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.Equal Opportunity Employer : We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
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