Job Details
Posted 22 May, 2026
Job Id: 628159
Engineer
Job Description
Job Description
The Device Engineer will support the design, development, and lifecycle management of commercialized drug delivery devices within a regulated design control environment. This role combines hands-on laboratory execution with technical operations support and sustaining engineering activities for combination products from development through global launch.
The engineer will support mechanical drug delivery devices, including prefilled syringes, through laboratory testing, design verification support, failure investigations, design change assessments, and maintenance of Design History File (DHF) documentation and traceability records. A key aspect of the role is understanding how testing activities support user needs, product requirements, risk controls, and verification strategies within the design control process.
This position requires a candidate who is comfortable working directly in the laboratory while applying structured engineering and documentation practices in a regulated environment. The engineer will collaborate cross-functionally with scientists, engineers, quality, manufacturing, and operations partners to support product improvements, technical investigations, inspection readiness activities, and execution of key project deliverables.
The successful candidate will demonstrate strong technical judgment, attention to detail, and the ability to connect day-to-day execution with broader product quality, compliance, and development objectives.
Ideal Candidate
The ideal candidate is a hands-on engineer with experience executing laboratory testing, troubleshooting technical issues, and working within regulated product development environments. They are detail-oriented, organized, and capable of producing high-quality technical documentation and reliable experimental results.
They understand how laboratory activities support broader design control objectives, including traceability, risk management, verification strategies, and product quality. This person is able to connect user needs, product requirements, and test outcomes within a structured development process.
The ideal candidate demonstrates strong ownership, sound engineering judgment, and effective collaboration skills. They are comfortable managing multiple priorities in a fast-paced environment and are proactive in using digital tools such as Smartsheet, electronic lab notebooks, data visualization tools, and AI-enabled productivity tools to improve coordination, workflow efficiency, documentation quality, and team communication.
Key Responsibilities
* 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.
Basic Qualifications
* 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.
Preferred Qualifications
* 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:
o ISO 13485 – Quality Management Systems for Medical Devices
o ISO 14971 – Risk Management for Medical Devices
o EU Medical Device Regulation 2017/745
Pay Rate Range: $30-44/hr depending on experience
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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