Manufacturing Process Engineer
3 weeks ago
At MillenniumSoft, we are seeking a highly skilled Manufacturing Engineer to join our team. As a key member of our engineering team, you will be responsible for leading multiple high-impact projects simultaneously, driving change, and contributing new ideas to improve manufacturing operations.
Key Responsibilities:
- Lead cross-functional project teams to improve manufacturing operational efficiency, optimize product design, and qualify replacement components.
- Develop and implement effective solutions to complex technical issues, often involving multiple disciplines such as mechanical, optical, electrical, and fluidic systems.
- Support the introduction of new products into manufacturing, reviewing engineering designs and documentation for completeness, clarity, and manufacturability.
- Interface with Product Development to define and implement manufacturability criteria, develop procedures for assembly, PCB testing, and system testing.
- Ensure designs, documents, and procedures have been validated in manufacturing prior to production release.
- Assess feasibility and soundness of proposed engineering evaluation tests, products, or equipment when necessary data is insufficient or confirmation by testing is advisable.
- Work independently with general instructions, receiving technical guidance on unusual or complex problems and supervisory approval on proposed plans for projects.
- Perform and document field failure investigations, identify root causes, and participate in corrective and preventive action efforts.
- Promote a safe work environment, provide recommendations on maintaining safety, and participate in Environmental, Health, and Safety programs.
Requirements:
- Typically requires a BS degree in Mechanical Engineering, Electrical Engineering, Industrial Engineering, Physics, or equivalent.
- 8+ years of experience in a high-tech manufacturing environment.
- Proficient in MS Office, MS Project, Visio, and Windows or MAC OS.
- Excellent written and verbal communication skills, with good interpersonal skills, conflict resolution, negotiation, and time management skills.
- Ability to understand engineering drawings, Bills of Materials, and operational procedures.
- Experience writing and reviewing Engineering Change Orders, developing manufacturing processes, and training assembly personnel.
- Strong project management experience, led continuous improvement efforts with cross-functional teams.
- Ability to assess and resolve multiple high-visibility problems in a timely manner.
- Familiarity with ISO 9001 and 13485 standards.
- Willingness to travel frequently.
Desirable Qualifications:
- M.S. degree.
- Proficiency with Pro-E, AutoCAD, Solidworks, MS Project, MS Access, SAP ERP, and Visio.
- Experience resolving technical issues involving lasers and optical components.
- Broad experience supporting commodities or supplier types such as lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA's, plastics, power systems, product packaging, turnkey subcontractors, hardware, and labeling.
- Strong cGMP familiarity 21 CFR part 820, medical industry experience.
- Experience implementing Demand Flow Technology (DFT) processes and LEAN manufacturing processes.
- 6 Sigma green or black belt.
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