Type:

full-time

Job Description:

Manufacturing Process Engineer Job Summary Responsible for driving manufacturing process improvement activities to support business objectives related to quality, productivity, cost, and compliance. Mechanical Engineering professional with 4+ years of experience in manufacturing processes and operations. Experience in the medical device or regulated manufacturing industry preferred. Roles & Responsibilities Support attainment of key business metrics through engineering support for manufacturing and value stream processes. Drive elimination of safety and quality risks through robust engineering solutions. Support machinery maintenance systems, equipment, fixtures, and manufacturing tooling. Lead cost reduction initiatives focused on scrap reduction, rework elimination, and consumable optimization. Develop and modify tools, fixtures, gauges, and special equipment in collaboration with internal teams and external vendors. Develop stable and capable manufacturing processes using structured process development methodologies. Perform process capability, scrap, and cost analyses to improve operational efficiency and reduce waste. Execute process validation activities, including IQ, OQ, and PQ, in accordance with Quality Management System (QMS) requirements. Conduct Process Risk Assessments and PFMEA activities to identify and mitigate potential failure modes. Prepare and maintain manufacturing specifications, work instructions, and technical documentation. Support validation of new materials, consumables, and process changes. Ensure timely closure of Audit Actions, NCRs, CAPAs, and other quality-related actions. Collaborate with cross-functional teams to support continuous improvement and operational excellence initiatives. Utilize standard business applications, including Microsoft Word, Excel, PowerPoint, Outlook, and project planning tools. Support laboratory controls, material evaluations, supplier validations, and material specification updates where applicable. Required Qualifications Bachelor's Degree in Mechanical Engineering or related discipline. Minimum 4 years of experience in Manufacturing Engineering, Process Engineering, or Operations. Experience in medical device manufacturing or other regulated industries. Knowledge of process validation, risk management, PFMEA, CAPA, NCR, and Quality Management Systems. Strong analytical, problem-solving, and communication skills. Ability to work effectively with cross-functional teams and external suppliers. Cygnus Belief We believe in our commitment to diversity & inclusion. Equal Employment Opportunity Statement Cygnus is an Equal Opportunity Employer. We ensure that no one should be discriminated against because of their differences, such as age, disability, ethnicity, gender, gender identity and expression, religion, or sexual orientation. All our employment decisions are taken without looking into age, race, creed, color, religion, sex, nationality, disability status, sexual orientation, gender identity or expression, genetic information, marital status, citizenship status, or any other aspects of employment protected by federal, state, or local law. Applicants for employment in the US must have work authorization & Cygnus does not offer any sponsorship of a visa for employment authorization in the United States. Thanks & Regards Amit Kumar Cygnus Professionals 3490 US Highway 1 Princeton, NJ 08540

M :

732 485 0000 Ext 9057 or 609-566-6868 (Direct)

F :

(888) 900-6979

E :

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Manufacturing Process Engineer (W2 only)