Manufacturing Engineer (Medical industry experience; New Product Introduction)

About the role

The Manufacturing Engineer (ME) will lead multiple high impact projects, contributing new ideas and finding innovative methods to accomplish goals. This role requires a BS degree in ME, EE, IE, Physics or equivalent with 8+ years of experience in a high tech manufacturing environment.

Responsibilities

• Leads cross-functional project teams to improve manufacturing operational efficiency, optimize product design, qualify replacement components, improve product quality, enhance customer satisfaction, and reduce manufacturing costs.
• Serves as a problem solver, determining root cause of difficult technical issues and implementing effective solutions in a timely manner.
• Reviews engineering designs and documentation for completeness, clarity, and manufacturability.
• Evaluates and qualifies new suppliers, and develops procedures/processes for assembly, PCB's, system and sub-system test procedures including fixtures.
• Ensures designs, documents, and procedures have been validated in manufacturing prior to production release.
• Affords assessments and resolves multiple high visibility problems in a timely manner.
• Works closely with Product Development to define and implement manufacturability criteria, and supports the introduction of new products into manufacturing.

Requirements

• Must have medical industry experience, New Product Introduction experience, and major - Electrical or Mechanical Engineering.
• Proficient in MS Office suite, MS Project, Visio, Windows or MAC OS.
• Excellent written and verbal communication skills, with good interpersonal skills like conflict resolution, negotiation, and time management.
• Extensive experience writing and reviewing Engineering Change Orders, and strong project management experience.
• Strong understanding of engineering drawings, Bills of Materials, and operational procedures.
• Experience with Pro-E, AutoCAD, Solidworks, MS Access, SAP ERP, Visio, and proficiency with ISO 9001 and 13485 standards.

Qualifications

• M.S. degree preferred.
• Experience with Pro-E, AutoCAD, Solidworks, MS Project, MS Access, SAP ERP, Visio.
• Broad experience supporting many of the following commodities or supplier types: lasers, optical components, fluidic systems, machined parts, sheet metal, cables, PCA’s, plastics, power systems, product packaging, turnkey subcontractors, hardware, labeling.
• Strong cGMP familiarity (21 CFR part 820), medical industry experience, and experience implementing Demand Flow Technology (DFT) processes, LEAN manufacturing processes, and 6 Sigma green or black belt.

Skills

• Problem-solving skills
• Project management
• Technical writing and review
• Supplier qualification
• Manufacturing process development
• Lean manufacturing
• 6 Sigma

Benefits

Includes comprehensive benefits package, competitive compensation, and opportunities for professional growth.

Pay

Competitive salary based on experience and qualifications.

Schedule

Full-time position with a 1st shift 8am-4pm schedule, onsite at client location in San Jose, CA.