Engineer II,Manufacturing

📁
Engineering
📅
191BB Requisition #

JOB SUMMARY:

Provide manufacturing engineering support to operations and product engineering. Lead Design for Manufacturing (DFM) analysis and provide feedback to design engineering.

 

ESSENTIAL/PRIMARY DUTIES:

  • Author and maintain manufacturing specifications, requirements, and Failure Modes and Effects

  • Analyses (FEMA) in accordance with protocols and FDA guidance documents

  • Author and lead process qualification via IQ, OQ & PQ process

  • Expert technical lead on design transfer in partnership with contract manufacturers.

  • Lead manufacturing fixture development, process development and qualifications

  • Conduct and manage structured design reviews

  • Identify improvement opportunities and lead the implementation of process improvements to reduce cost, improve changeover, increase quality and repeatability.

  • Lead maintaining work instructions.

  • Leads the design, implementation and optimization of manufacturing processes

  • Develop and execute process and product validations.

  • Perform Process FMEAs

  • Maintain costing and routing information for parts and assemblies.

  • Collaborate with Product Engineering to develop and design component processes for new parts and lead the DFM process.

  • Improve tooling to reduce expenses.

  • Work with outside suppliers to enhance, improve and solve problems.

  • Work with design engineering on product design and tooling to ensure efficient production methods.

  • Execute plant layouts.

  • Evaluate process for most cost effective manufacturing process.

  • Design tools and fixturing to improve the work piece holding capability for assembly and machining processes.

  • Write and execute validation protocols.

  • Lead and manage projects to meet department goals and objectives.

  • Lead capital equipment projects

  • Lead sourcing changes from in-house to supplier and vice versa to meet demand and capability changes.

  • Lead cross functional teams.

  • Provide guidance among engineers and co-ops

  • Analyze and design parts and assemblies to applicable standards.

  • Provide technical data and assist in decision making process to ensure compliance with design specifications.

  • Participate in all phases of design, including design analysis, testing of design and qualification of the design for production and sale to the public.

  • Participate in projects teams. Responsible for planning and organizing work to meet project goals.

  • Create documents related to the design engineering function.  Documentation includes, but is not limited to: layout drawings, detail drawings, assembly drawings, Bills of Materials, Engineering Change Orders and design records.

  • Help create documentation required to ensure the product can be produced as designed.

  • Assist in developing product and component test specifications.

  • Participate as a member of product research teams to acquire detailed product and user knowledge

SECONDARY DUTIES:

  • Research and lead new capabilities for future demand and production needs.
  • Develop tooling for sheet metal and plastic part production.

EDUCATION and/or EXPERIENCE:

  • Bachelor/Master in Science, Manufacturing, Mechanical engineering preferred and 5 or more years of experience in an engineering role or equivalent combination of education and experience preferred.

COMPETENCY/SKILL REQUIREMENTS:

 
  • Experience with 3D solid modeling skills, Pro/E preferred

  • Ability to read Bill of Materials

  • Ability to follow instructions

  • Proficient in Microsoft Office Suite

  • Ability to multitask and problem solve

  • Knowledge of Enterprise Resource Planning (ERP) systems.  Oracle preferred. PLM Agile preferred.

  • Ability to analyze and interpret data

  • Ability to prepare Test Protocols and Test Reports

  • Attention to detail

  • Ability to work independently and collaboratively

  • Strong analytical and communication skills (written & verbal)

  • Ability to read engineering documents

  • Ability to work under pressure and meet deadlines

  • Knowledge of Lean principles and concepts

  • Knowledge of FDA and ISO regulations

  • Ability to mentor and share knowledge

  • Lead by influence throughout the organization

  • Ability to understand customer and market needs

  • Strong planning and organizational skills

  • Strong mathematical and technical abilities

  • Ability to lead and manage projects and/or project teams

  • Ability to work with limited direct supervision

  • Proficient in the subject matter or the functional areas of the assignments and influence the project team for the best practices related to that area

  • Knowledgeable of the fundamental theory and the practical application of engineering science and technology

  • Ability to apply principles, techniques, procedures, and equipment to the design and production of medical devices and services

  • Awareness of CNC programming

  • Experience with 2D design software, AutoCAD preferred

  • Ability to work with mathematical concepts such as probability and statistical inference, and fundamental



 
SUPERVISORY RESPONSIBILITIES:
  • N/A

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