Senior Manufacturing Process Engineer

What You'll Work On

• Own and maintain manufacturing processes, ensuring alignment with product specifications, process capabilities, and test method requirements.
• Lead process and equipment improvement initiatives to enhance quality, efficiency, throughput, and cost performance.
• Evaluate and implement manufacturing and design alternatives using Design for Manufacturability (DFM) principles.
• Solve complex technical challenges using structured problem-solving methodologies, statistical tools, and data-driven decision making.
• Design and execute engineering studies, including DOE methodologies, to support process optimization and validation activities.
• Lead equipment implementation, startup, qualification, and process validation activities, including IQ/OQ/PQ protocol development and execution.
• Ensure compliance with Design Controls, Process Validation requirements, FDA regulations, ISO standards, cGMP requirements, and internal Quality Management System (QMS) processes.
• Support Quality Incidents, CAPA investigations, root cause analysis, and implementation of corrective and preventive actions.
• Analyze raw material specifications and lead evaluations, testing, and validation activities associated with material changes.
• Develop, revise, and maintain manufacturing documentation, including SOPs, work instructions, specifications, validation protocols, risk assessments, and engineering procedures.
• Conduct audits and assessments to ensure compliance with regulatory, quality, and operational standards.
• Lead technical reviews for manufacturing equipment, process changes, product design, and engineering requirements.
• Research and implement new manufacturing technologies and engineering solutions to improve operational performance.
• Drive change management activities through Agile PLM/PDM systems and established engineering change processes.
• Collaborate effectively with cross-functional teams, including Manufacturing, Quality, R&D, Supply Chain, Maintenance, and Regulatory Affairs.
• Mentor and provide technical guidance to engineers and technicians to support continuous improvement, compliance, and operational excellence.
• Ensure compliance with all applicable FDA, ISO, environmental, safety, and company policies, including OSHA requirements.
• Support continuous improvement initiatives and organizational objectives in support of quality, operational, and business goals.

Required Qualifications

• Bachelor's degree in Engineering or an equivalent combination of education and experience.
• 7+ years of engineering experience in a manufacturing environment.
• Technical expertise in Mechanical, Biomedical, Industrial, Chemical, or a related engineering discipline.
• Experience performing engineering calculations, designed experiments, controlled testing, and statistical analysis.
• Proficiency with Microsoft Office applications, including Excel, PowerPoint, and Power BI.
• Experience with change management principles and practices.

Preferred Qualifications

• Experience working in a regulated manufacturing environment operating under FDA, ISO, or comparable quality systems.
• Working knowledge of cGMP requirements and ISO 13485 standards.
• Proficiency with statistical analysis software such as Minitab or JMP.