Overview
On Site
Full Time
Skills
Pharmaceutics
Lifecycle Management
Regulatory Compliance
System Requirements
ISO 13485
Technical Writing
Inventory
Research and Development
Human Factors And Ergonomics
Manufacturing
Requirements Management
Risk Management
FMEA
Continuous Improvement
Test Methods
Documentation
Management
Functional Design
Product Development
Mechanical Engineering
Biomedicine
Electrical Engineering
Medical Devices
Electromechanics
Data Analysis
Reporting
Design Controls
Collaboration
Testing
Logistics
Statistics
Minitab
Communication
Job Details
USTO - 3-5 days onsite depending on business needs - Standard hours
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.
Client 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 at Client 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 Client'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.
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.
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.
Client 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 at Client 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 Client'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.
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.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.