Engineer – Sustaining, R&D

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, 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.

• BS in Engineering, or equivalent technical discipline.
• Minimum of 2 years of previous experience in a related field (e.g., medical device design and manufacturing, or similar regulated industry, plastic processing, injection molding).
• Basic understanding of mechanical systems, fluid dynamics, and material properties related to vascular access devices.
• Familiarity with CAD modeling (Solid Works) 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.

• BS in Engineering
• ISO 14971