Device Engineer

• Support the design, development, and lifecycle management of commercialized drug delivery devices within a regulated design control environment.
• Contribute to sustaining engineering activities for mechanical delivery devices, including prefilled syringes, with responsibility for DHF maintenance, traceability, lifecycle documentation, and product improvements.
• Plan, coordinate, and execute laboratory testing for device characterization, verification, design transfer, fill-finish support, and technical investigations.
• Develop, execute, and document test methods, protocols, technical assessments, and reports using sound engineering principles and GMP documentation practices.
• Ensure testing activities are clearly linked to user needs, design inputs, product requirements, risk controls, specifications, and verification objectives.
• Analyze and interpret experimental data using engineering judgment and statistical tools to support technical decisions, investigations, design changes, and specification assessments.
• Support root cause analysis, failure investigations, deviations, nonconformances, risk assessments, and design or manufacturing change evaluations.
• Partner with engineering, quality, manufacturing, operations, and scientific teams to support product enhancements, launch activities, inspection readiness, and cross-functional deliverables.
• Contribute to continuous improvement efforts that strengthen lab efficiency, testing reliability, documentation quality, traceability, and project visibility.
• Use tools such as Smartsheet, Excel, electronic lab notebooks, data analysis platforms, and AI-enabled productivity tools to improve project coordination, workflow management, communication, and operational efficiency.

• Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, Bioengineering, or a related engineering or scientific discipline.
• Experience working in a regulated laboratory, medical device, pharmaceutical, biotechnology, or combination product environment.
• Ability to independently plan, execute, document, and evaluate technical work using sound engineering or scientific principles.
• Experience supporting laboratory testing, technical assessments, investigations, or product development activities.
• Experience authoring or reviewing technical documentation in a regulated environment, such as protocols, reports, assessments, or investigation summaries.
• Strong organizational skills with the ability to manage multiple priorities, maintain accurate records, and follow through on commitments.
• Effective written and verbal communication skills with the ability to collaborate across technical and cross-functional teams.

• Bachelor’s degree or higher in a relevant engineering or scientific field
• Experience with medical device, combination product, or regulated product development, particularly within a design control environment.
• Familiarity with design controls and traceability across user needs, design inputs, product requirements, risk controls, specifications, and verification/validation activities.
• Understanding of how intended use, user needs, and risk management inform testing strategies, requirements, and design decisions.
• Experience supporting Design History File documentation, traceability matrices, design verification, design changes, or lifecycle management activities.
• Hands-on laboratory experience with device characterization, test method development, fixture design, GR&R, or mechanical testing.
• Experience with Instron force testers, BlueHill Universal, electronic lab notebooks, and statistical analysis tools such as Minitab or JMP.
• Experience supporting investigations, deviations, nonconformances, root cause analysis, risk assessments, or change control records.
• Experience using digital tools such as Smartsheet, Excel, data visualization tools, electronic lab notebooks, or AI-enabled productivity tools to improve project tracking, workflow efficiency, documentation quality, and team communication.
• Strong technical writing, presentation, and stakeholder communication skills.
• Ability to work independently and collaboratively across dynamic, cross-functional teams while supporting complex workstreams under demanding timelines.
• Understanding of applicable regulations and standards, including:

• 21 CFR 820 – Quality System Regulation
• ISO 13485 – Quality Management Systems for Medical Devices
• ISO 14971 – Risk Management for Medical Devices
• EU Medical Device Regulation 2017/745

• -Hands-on device testing and lab execution
• -Experience working in a regulated design control environment
• -Strong technical documentation, data analysis, and digital tool skills

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