Process Engineer Jobs

About The Position

Requirements

• Bachelor’s degree in Engineering or an equivalent combination of education and experience.
• At least 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.

Nice To Haves

• Experience 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.
• Experience with CAD and related engineering software for equipment, tooling, and process design.
• Experience with Quality Management Systems and change control in regulated environments.
• Ability to interpret technical specifications, engineering drawings, schematics, and complex instructions.
• Knowledge of statistical methods, probability concepts, ANSI/AQL sampling plans, and engineering calculations.
• Understanding of manufacturing financial metrics, including COGS, capital investments, inventory management, profitability, and cost reduction.
• Data analytics skills to use manufacturing and quality data for process improvement and business decisions.
• Competencies in multitasking, verbal and written communication, analytical thinking and problem solving, strategic planning, and vendor management.

Responsibilities

• Own and maintain manufacturing processes to ensure alignment with product specifications, process capabilities, and test method requirements.
• Lead process and equipment improvements to enhance quality, efficiency, throughput, and cost performance.
• Evaluate and implement manufacturing and design alternatives using Design for Manufacturability principles.
• Solve technical challenges using structured problem-solving methods, statistical tools, and data-driven decision-making.
• Design and execute engineering studies, including Design of Experiments, for process optimization and validation.
• Lead equipment implementation, startup, qualification, and process validation, including development and execution of IQ/OQ/PQ protocols.
• Ensure compliance with Design Controls, Process Validation requirements, FDA regulations, ISO standards, cGMP requirements, and internal Quality Management System processes.
• Support Quality Incidents and CAPA investigations, perform root cause analysis, and implement corrective and preventive actions.
• Analyze raw material specifications and lead evaluations, testing, and validation 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 for regulatory, quality, and operational compliance.
• Lead technical reviews for manufacturing equipment, process changes, product design, and engineering requirements.
• Research and implement manufacturing technologies and engineering solutions to improve operational performance.
• Drive change management through Agile PLM/PDM systems and established engineering change processes.
• Collaborate with Manufacturing, Quality, R&D, Supply Chain, Maintenance, and Regulatory Affairs.
• Mentor and provide technical guidance to engineers and technicians.
• Comply with applicable FDA, ISO, environmental, safety, company, and OSHA requirements.
• Support continuous improvement initiatives and organizational quality, operational, and business objectives.
• Exhibit professional behavior with internal and external business partners, understand quality and compliance implications of assigned work, support departmental objectives, and perform other related duties as assigned.

Benefits

• Potential eligibility for free medical coverage in the Health Investment Plan (HIP) PPO medical plan in the next calendar year.
• Retirement savings plan with a high employer contribution.
• Tuition reimbursement.
• Freedom 2 Save student debt program.
• FreeU education benefit, an affordable and convenient path to a bachelor’s degree.
• Career development opportunities.