Manufacturing Process engineer - North Haven, United States - Katalyst HealthCares & Life Sciences

Description

Responsibilities:
Participate in Design for Assembly (DFA) / Design for Manufacturing (DFM) activities to verify manufacturability of Product Designs.

Actively participate in PFMEA, DFMEA, Process Mapping, and Critical to Quality (CTQ) reviews assuring specifications are well defined and documented.

Create and review process flow charts, assembly tooling strategies, assembly line layouts, balance tables, assembly capacity analysis, and EHS project plans.

Participate in the development of capital expense requests, project schedules, make-buy analysis and other financial documents.

Provide input for all assembly tooling required to support new product development activity

Create, assemble, detail and review tooling and fixturing utilizing Creo and Solidwork's software.

Develop and review defining documents, RFQ packages, interact with suppliers during the quoting process, ensure supplier adherence to tooling specifications, oversee manufacture and qualification of assembly tooling.

Develop Protocols and execute Factory Acceptance Testing (FAT) on all purchased tooling, systems and fixtures.

Manage and support line validation / qualification activities for including IQ, OQ , MSA and PQ.

Write testing protocols for product evaluations; oversee and analyze product evaluation requests.

Create process documentation including SWI, Control Plans and job safety analysis sheets.

Actively participate in Lean initiatives to stabilize production lines and reduce the time to transfer to Plant.


Requirements:
Experience in CREO to review custom tooling, fixtures, gages, and components.

Review modification and development of Machine Specifications for manual, semi-automated and fully automated machines

Basic understanding of Industrial Engineering principles including balance tables, process flow diagrams, line Client-outs, ergonomic designs, etc.

Experience in assembly equipment technologies

Experience with equipment and line process validations (IQ / OQ / PQ / MSA's)

Working knowledge of Lean Principles and/or 6 Sigma Methodology

Working knowledge of GD&T

Working knowledge of FMEA

Working knowledge of DFA and DFM principles BS Mechanical Engineering or Mechanical Engineering Technology

BS Manufacturing Engineering or Manufacturing Engineering Technology

3 Years Applicable Experience for mid-Level

7 years Applicable Experience for Senior level

Familiarity with statistical analysis including capability, process control, DOE's, control charts, etc.

Minitab experience preferred, but not mandatory

Experience or working knowledge of control systems, PLC logic, and vision systems.

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