Engineer, Mechanical II

At Vante, a Machine Solutions company, we develop advanced manufacturing solutions that help the world’s leading medical device companies bring life-changing technologies to market. We are seeking an experienced Mechanical Engineer to perform sustaining engineering tasks with moderate independence, including production support, NCR investigation, ECN execution, DVT/VT and FAI support, BOM issue resolution, test support, CAPA support, and process improvement.

Essential duties and responsibilities:

• Provide production support for mechanical issues, including troubleshooting, documentation review, and corrective actions.
• Support urgent NCRs and second-level production NCRs by investigating causes and recommending containment or correction.
• Execute ECNs for obsolescence, alternate components, redesigns, and DVT/VT-related changes with senior review.
• Support DVT/VT planning, test execution, data review, and documentation.
• Support test activities related to obsolescence, alternate parts, FAIs, and design verification.
• Support CAPA investigations through failure analysis, root-cause input, redesign support, and verification activities.
• Investigate and resolve routine BOM issues and maintain tracking records.
• Create or revise drawings, parts, assemblies, and documentation in CAD/PDM and ERP systems.
• Assist with process creation, process improvement, and KPI tracking for BOM issues, NCRs, and ECNs.
• Provide day-to-day guidance to interns or Level I engineers on assigned tasks.

Qualifications

Education and Experience:

• Bachelor’s degree in Mechanical Engineering or related field, or equivalent combination of education, training, and experience. Typical experience: 2–5 years.

Technical Competencies:

• Working knowledge of mechanical design, production troubleshooting, drawing updates, BOM issue resolution, ECN execution, NCR support, DVT/VT support, FAI support, test support, and CAPA-related failure analysis. Ability to resolve routine mechanical issues with moderate independence.

Tools and Systems:

• Working proficiency with SolidWorks, EPDM/PDM, ERP/M1, engineering drawings, BOM structures, test documentation, Microsoft Office, and engineering documentation systems.

Quality, Compliance, and Process Knowledge:

• Working knowledge of GMPs, ECNs, NCRs, CAPA support, DVT/VT, FAI, documentation control, and manufacturing-support workflows.

Problem Solving and Reasoning:

• Ability to solve routine mechanical problems, investigate causes, recommend containment or corrective actions, and escalate complex issues appropriately.

Communication and Collaboration:

• Ability to communicate technical findings, documentation updates, risks, and task status with engineering, production, quality, procurement, and operations teams.

Leadership and Mentoring:

• May guide interns or Level I engineers on assigned day-to-day tasks.

Preferred Qualifications:

• Experience in manufacturing support, mechanical troubleshooting, CAD/PDM workflows, regulated manufacturing, BOM control, ECNs, NCRs, or CAPA support.

Work Environment:

• Minimal time will be spent near fumes or airborne particles, near toxic or caustic chemicals, in outdoor weather conditions, with risk of electrical shock, and with explosives. Sometime will be spent working near moving mechanical parts. Moderate noise can be expected.

• Why Join Vante?

• Lead a team that directly impacts customers and product innovation.

• Work with cutting-edge medical device manufacturing technologies.

• Influence engineering strategy and shape the future of our Applications Engineering organization.

• Join a collaborative, fast-paced environment focused on growth, innovation, and continuous improvement.

• Help deliver technologies that support the advancement of patient care worldwide.