Manufacturing Engineer II @ Midmark Corporation - Torrance, CA
Manufacturing Engineer II
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- Author and maintain manufacturing specifications, requirements, and Failure Modes and Effects
- Author and maintain manufacturing procedures, ESD procedures, soldering re-work rocedures, etc.
- 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
- 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 Electronics or Electrical Engineering, Manufacturing, or Mechanical engineering and 5 or more years of experience in an engineering role or equivalent combination of education and experience preferred
- Experience with electronic device assembly
- Experience with developing and maintaining automated test equipment like bed of nails board test benches
- Experience with National Instruments (NI) programming
- 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
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Midmark is the only clinical environment design and manufacturing company that enables a better care experience at the point of care in medical, dental and animal health. By harmonizing space, technologies and workflows, we enhance interactions between patients and caregivers resulting in more efficient care and better outcomes. By living our corporate values, our 2,000 teammates worldwide make this possible.