Associate Project Engineer - Sustaining

Position Summary

The Associate Project Engineer – Sustaining supports product life cycle efforts for vascular access devices through data-driven design maintenance and quality improvements. This role assists in implementing product changes, developing technical documentation, and participating in labeling, CAPA, and system activities. The engineer collaborates across functional teams to support product reliability and compliance while gaining experience in sustaining engineering processes within a regulated medical device environment.

Principal Responsibilities

•    Assist in implementing product changes using predefined project scopes and sustaining engineering protocols.
•    Conduct basic engineering assessments of change impacts on product families and downstream systems.
•    Support simple labeling updates in compliance with product and regulatory requirements.
•    Perform Agile system tasks such as document retrieval and DMR navigation for change execution.
•    Contribute to documentation accuracy for change control processes including engineering drawings and specifications.
•    Aid in assessing and resolving product quality issues under guidance.
•    Assist in CAPA and NC documentation by gathering data, documenting investigation findings, and tracking actions.
•    Participate in quality improvement activities to address common manufacturing or customer-reported issues.
•    Observe and document product performance in support of minor design refinements or updates.
•    Gather cross-functional input during project planning and change execution.
•    Assist in the preparation of project summaries and engineering justifications for regulatory submission.
•    Provide support during early production runs by helping identify and track defects or inconsistencies.
•    Perform basic SAP tasks such as material lookups and BOM reviews.
•    Collaborate with senior engineers and team leads to prioritize sustaining tasks in alignment with business needs.
•    Ensure accurate documentation and clear communication throughout the change process to support compliance and traceability.

Education / Experience Requirements

•    Bachelor’s degree in Mechanical Engineering, Biomedical Engineering, or related technical field.
•    0–2 years of experience in a regulated product development or sustaining engineering environment.
•    In lieu of a degree, a minimum of 4 years of relevant experience in medical device manufacturing or R&D settings.

Specialized Skills / Other Requirements

COMPLEMENTARY SKILLS FOR CROSS FUNCTIONAL AWARENESS: Knowledge areas outside of the core responsibilities that enable the individual to collaborate effectively across teams and tailor work products to broader business needs.
•    General awareness of product groupings and types within vascular access.
•    Understands the basic clinical use of vascular access devices and related workflows.
•    Observes clinical environments and participates in product demos for context.
•    Supports basic CAD model review and interpretation.
•    Participates in preliminary risk activities such as DFMEA with supervision.
•    Understands verification test planning and execution needs.
•    Learns the principles of design validation and summative testing.
•    Demonstrates basic awareness of user needs and human factors considerations.
•    Understands introductory regulatory concepts such as ISO 13485 and FDA 21 CFR 820.
•    Recognizes the purpose of formative testing and clinical input during development cycles.

BEHAVIORAL COMPETENCIES: Personal attributes and leadership behaviors that contribute to team success, collaboration, and individual influence within a technical organization.
•    Demonstrates a learning mindset with initiative to take on new tasks.
•    Collaborates effectively across teams, building early trust and reliability.
•    Completes tasks with attention to detail and quality under supervision.
•    Actively listens and contributes to team discussions when possible.
•    Seeks feedback and adapts quickly to evolving project needs.
•    Demonstrates respect for different perspectives and team dynamics.
•    Follows company policies, ethics, and safety guidelines consistently.
•    Connects daily work with broader company goals and team outcomes.

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