Description:

The Manufacturing Engineer III supports new product Introduction and existing products improving productivity, efficiency and yield. Leads assembly line and equipment qualifications and manufacturing process changes. Develop master validation plans and appropriate protocols and report. Creates and maintainsdocumentation to comply with FDA and ISO regulations.Provide technical support to existing products and processes using structured methods based on Lean Manufacturing and Six Sigma methodologies.

Key Responsibilities:

Creates and maintain proper manufacturing documentation as SOP’s, Operator and process instructions, forms and reports.
Assembly line incorporation based on lean manufacturing principles
Assures ISO and FDA regulation compliance

Responds to CARS, NCR, and SCRs with definitive solutions that eliminate recurrence and promote process improvement.

Interacts with customer to answer corrective actions, engineering changes and supplier change requests.
Develops and execute cost reduction and continuous improvement projects applying Lean manufacturing and Six Sigma principles.
Designs and implements fixtures and jigs to improve manufacturing operations (assembly, inspection, visual aids, etc)
Identifies, structures and executes continuous improvement activities (Opex events), cost reduction initiatives and efficiency improvement projects.

Determine root cause analysis, and implement corrective and preventive action plans.Develop, write, and execute Validation Protocols (IQ/OQ/PQ), reports, internal audits, work instructions.Analyses Data (SPC, DOE,) to find causes of variation and address proper correction or improvement.

Monitors KPI’s and overall performance of assembly lines and secondary operations to identify improvement opportunities.
Reviews, maintain BOMs and routings up to date in accordance with improvements and modifications to new or existing processes.

Qualifications

Bachelor’s degree in Engineering (Industrial, Manufacturing, Electro-Mechanical or equivalent)
Hands on experience
Experienced in MS office tools (Word, Excel, Powerpoint, Project etc.)

Experience with CAD Software (Solid Works & AutoCAD) preferred.
Experience with Data Analysis software (Minitab)

lean manufacturing and Six Sigma black belt certification or higher required

Requirements, Skills & Experience:

8 - 10 years experience in the position
Work and Time studies
FDA and ISO regulated environment.
Secondary Operations qualification
Assembly line development. Line balancing, One piece flow and JIT focus
MRP experience IQMS or similar
BOMs and routing creation and modification
Self-motivated, requiring minimum supervision
Software familiar: Microsoft office, Minitab, Project, Autocad

We offer market competitive compensation. Potential salary range for this role is $120,000-$135,000. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law.

Viant is a global medical device design and manufacturing services provider that partners and innovates with customers to provide the highest quality, life enhancing medical devices. We do this through our depth and breadth of capabilities, end-to-end integration, technical expertise, and relentless focus on our customers and on operational excellence. With nearly 6,000 associates across 24 locations worldwide, we offer a unique combination of small-company service and attention with big-company resources. For more information, visit viantmedical.com or follow us on LinkedIn.

Viant provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, national origin, age, disability, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state, and local laws. Viant complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.

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