Manufacturing Engineer

Responsibilities

Drive continuous improvements in product quality, yield, and process efficiency.

Develop, validate, and implement robust PCBA manufacturing processes.

Support qualifications of new equipment and tooling for PCBA processes.

Support new product introduction and ensure alignment with business goals.

Provide day‑to‑day technical support to resolve production issues, improve yields, and reduce scrap / rework.

Lead root cause analysis and corrective / preventive actions (CAPA) for process deviations and non‑conformances.

Work closely with R&D, Quality, Supply Chain, and Operations to support new product introductions (NPI), Cost Improvement Projects.

Actively engage in resolving internal quality issues observed during production to ensure uninterrupted manufacturing flow and adherence to the build plan.

Provide manufacturing feedback during design reviews and support design for manufacturability (DFM) efforts.

Maintain accurate and up‑to‑date process documentation, including BOM, manufacturing procedures, work instructions, and control plans.

Ensure compliance with Abbott’s quality system, FDA regulations, ISO 13485, and other applicable standards.

Support internal and external audits, including preparation of documentation, process walkthroughs, and implementation of corrective actions as needed.

We Are Looking For

• Bachelor’s degree in Mechanical Engineering, Electrical & Electronics Engineering, or a related engineering discipline.
• Demonstrated ability to lead process validation activities including IQ / OQ / PQ and generate supporting documentation.
• Knowledge of IPC standards such as IPC‑A‑610, IPC‑TM‑650 and IPC‑7711 / 7721 for electronic assemblies is a plus.
• Basic understanding of quality tools and methodologies (e.g., 5 Whys, Fishbone Diagram, FMEA, SPC).
• Familiarity with ISO 13485, FDA 21 CFR Part 820, and other applicable regulatory requirements.
• Strong analytical and problem‑solving skills.
• Good communication and documentation skills.
• Proficient in Microsoft Office (Excel, Word, PowerPoint); experience with Power BI, SQL is a plus.
• Ability to work independently and in a team‑oriented environment.
• Knowledge of MES, ERP systems, and digital manufacturing tools for traceability and process control.

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