Bachelor's degree in Engineering or a related technical discipline.
Minimum 7 years of relevant manufacturing engineering experience; an advanced degree with 5+ years of experience may be considered.
Proven experience supporting medical device manufacturing operations.
Strong background in process validation, including protocol development, execution, and reporting.
Demonstrated experience in equipment qualification and manufacturing change control.
Hands-on experience with semi-automated manufacturing equipment and assembly systems.
Knowledge of PLC-controlled equipment and machine interfaces.
Experience with vision inspection systems and automated manufacturing equipment.
Strong understanding of OEE analysis, capacity planning, yield improvement, and scrap reduction.
Proficiency in root cause analysis methodologies and structured problem-solving.
Ability to lead technical decision-making, project execution, and cross-functional initiatives.
Experience mentoring engineers and providing technical leadership in a manufacturing environment.
Manufacturing engineering experience in a regulated environment, with familiarity in FDA Quality System Regulations and ISO requirements.
Experience with SAP or similar enterprise systems for manufacturing or operations.
Demonstrated capability in continuous improvement within manufacturing operations.
Experience with new product introduction (NPI) and manufacturing scale-up activities.
Background in medical device manufacturing, including understanding of regulatory and quality expectations.
Experience with automation projects, including PLC systems and vision inspection systems integration.
Exposure to capital equipment planning, selection, installation, and validation.
Experience with statistical process control (SPC) and data-driven process optimization.
Demonstrated success in yield improvement, capacity planning, and scrap reduction initiatives.
Technical project leadership experience, including managing timelines, risks, and cross-functional coordination.
Experience with technology transfer from R&D; or pilot lines into full-scale manufacturing.
Familiarity with manufacturing strategy development and implementation.
Comfort working with large-scale enterprise systems such as SAP for production and materials management.
