Lead new product introduction (NPI) activities, ensuring smooth transfer of designs into full-scale manufacturing.
Collaborate with cross-functional teams (quality, supply chain, scheduling, operations, design engineering) to meet project timelines and deliverables.
Develop, implement, and sustain robust manufacturing processes to meet customer, site, and regulatory requirements.
Drive process validation, equipment qualification, and documentation updates to ensure compliance with FDA, ISO 13485, and other relevant standards.
Provide on-the-floor technical support, troubleshooting equipment and process issues to minimize downtime and maximize efficiency.
Partner with suppliers and vendors to specify new equipment, materials, and tooling as needed.
Lead or support capital improvement projects and continuous improvement initiatives to reduce cost, improve quality, and increase throughput.
Act as a liaison between manufacturing and customers during product launch and ongoing support.
Contribute to risk assessments, root cause investigations, and implementation of corrective/preventive actions (CAPA).
Maintain accurate documentation in line with Good Manufacturing Practices (GMP) and company policies.
Support CNC machining processes — including programming, process optimization, and troubleshooting — to ensure efficient, high-quality production of precision components.
Qualifications
Bachelor’s degree in Engineering (Mechanical, Manufacturing, Biomedical, Industrial, or related field).
5+ years of experience in a manufacturing engineering role, preferably within medical device, pharmaceutical, or other regulated manufacturing environments.
Strong knowledge of process validation, equipment qualification, and regulatory compliance (FDA, ISO 13485, GMP).
Proven experience with new product introduction (NPI) and tech transfer from R&D to manufacturing.
Hands-on experience with CNC machining processes, equipment, and tooling.
Familiarity with injection molding, assembly, or packaging processes in regulated industries is a plus.
Experience troubleshooting production equipment and supporting daily operations.
Knowledge of Lean, Six Sigma, or other continuous improvement methodologies.
Strong project management, problem-solving, and communication skills.
Ability to collaborate with cross-functional teams and manage multiple priorities simultaneously.
