Engineer, Mechanical II

United States·Tucsonmid

OtherMechanical

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Quick Summary

Key Responsibilities

Provide production support for mechanical issues, including troubleshooting, documentation review, and corrective actions.

Requirements Summary

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

Technical Tools

OtherMechanical

Machine Solutions is the premier provider of advanced equipment and services for the medical device, biopharmaceutical, and blood- and plasma-collection industries. We support our customers’ needs and growth by delivering quality and value through a wide breadth of products. Machine Solutions provides proprietary mechanical solutions to a variety of complex process, testing and device design challenges. Our equipment has become the industry standard for stent crimping, balloon catheter pleating and folding, catheter braiding and medical device manufacturing applications. As a pioneer in radio frequency technology, the company has continued to develop advancing technology for thermal forming, molding and welding plastic for medical manufacturing, biopharmaceutical, and blood- and plasma-processing applications. Our experienced team of engineers has been instrumental in automating manual processes that enable our customers to increase production volumes and profit margins, and we believe in providing a superior customer experience by designating resources to a dedicated aftermarket team that is always ready to provide technical service and process support. Machine Solutions is privately owned by BW Forsyth Partners, a Barry-Wehmiller company.

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.

Responsibilities

~1 min read

→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.

Requirements

~1 min read

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.

Machine Solutions, Inc.

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.

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

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

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

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

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