Project Engineer

Position Summary

The Project Engineer is responsible for supporting the ongoing lifecycle management of vascular access devices, ensuring product quality, regulatory compliance, and manufacturing efficiency. This role focuses on analyzing design changes, conducting verification and validation activities, and collaborating with cross-functional teams to implement product improvements while maintaining alignment with business objectives and industry regulations. The engineer will work to resolve product and process issues, optimize manufacturing processes, and support design transfer activities.

Principal Responsibilities

•    Assist in analyzing market segments and competitive products to understand product positioning and identify areas for improvement.
•    Support product evaluations and clinical interactions to understand user needs, device applications, and clinical workflows.
•    Provide engineering support for product demonstrations, basic clinician interactions, and product troubleshooting.
•    Apply engineering principles to evaluate product design changes, ensuring compliance with regulatory and quality standards.
•    Contribute to design verification and validation activities, including developing test protocols, executing tests, and analyzing results.
•    Assist in risk management activities, including DFMEA, UFMEA, and hazard analysis, under the guidance of senior engineers.
•    Support design documentation, including updating Design History Files (DHF) and Device Master Records (DMR), ensuring compliance with ISO 13485 and FDA 21 CFR 820 requirements.
•    Collaborate with process development teams to ensure design outputs are compatible with manufacturing requirements and scalability.
•    Participate in sustaining engineering activities such as troubleshooting product performance issues, implementing design improvements, and ensuring manufacturability.
•    Work with regulatory teams to ensure product changes and updates meet compliance requirements.
•    Support the execution of process validation studies (IQ, OQ, PQ) and contribute to process control improvements.
•    Assist in root cause analysis, CAPA (Corrective and Preventive Actions), and non-conformance resolution efforts.
•    Develop familiarity with SAP, Agile PLM, and quality systems to support engineering changes, product tracking, and documentation management.
•    Engage in technical report writing, including summarizing test data, engineering analysis, and change justifications.
•    Contribute to product labeling verification, documentation updates, and engineering change requests (ECRs) as part of sustaining efforts.
•    Collaborate with supply chain and operations teams to ensure smooth implementation of design changes and material substitutions.
•    Participate in technical discussions, cross-functional meetings, and project team collaborations to support business objectives.
 

Education / Experience Requirements

•    BS in Engineering, or equivalent technical discipline.
•    Minimum of 2 years of previous experience in related field (e.g. medical device design and  manufacturing, or similar regulated industry, plastic processing, injection molding).

Technical Knowledge:
•    Basic understanding of mechanical systems, fluid dynamics, and material properties related to vascular access devices.
•    Familiarity with CAD modeling (SolidWorks) and ability to create and modify 3D models and 2D drawings.
•    Awareness of Design for Manufacturability (DFM) principles and basic ergonomic considerations in medical device design.
•    Understanding of verification and validation principles, including ISO 14971 risk management.
•    Ability to perform basic statistical analyses using Minitab or equivalent software.
•    Exposure to design control processes and regulatory requirements, including ISO 13485 and FDA 21 CFR 820.
Regulatory and Compliance:
•    Familiarity with design control processes, regulatory requirements, and quality standards for medical devices.
•    Understanding of design verification and validation, risk management, and usability engineering principles.
•    Awareness of change control processes, including ECOs (Engineering Change Orders) and CAPA procedures.
Process Development and Manufacturing Support:
•    Basic knowledge of process validation, including IQ, OQ, and PQ requirements.
•    Exposure to PFMEA and risk assessment tools related to manufacturing and design transfer.
•    Understanding of material variability and manufacturing process adjustments to improve consistency and efficiency.
Project Management and Collaboration:
•    Strong documentation skills, including writing test reports, design justifications, and regulatory submissions.
•    Ability to work in cross-functional teams, collaborating with R&D, quality, regulatory, manufacturing, and clinical teams.
•    Effective communication skills to present technical information clearly and collaborate with internal and external stakeholders.
 

Specialized Skills / Other Requirements

TRAVEL REQUIRED: <5 %

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