- Provides technical support to Management, Business Development, Engineering, Manufacturing, QA/RA, and Purchasing as needed or when requested.
- Creates and develops designs from customer requirements to proof of concept to fully actualized and commercialized products.
- Evaluates and troubleshoots problems, issues, or challenges in the design that may affect performance, manufacturing, inspection, and assembly processes to provide solutions.
- Must be able to perform and demonstrate all developed and existing manufacturing, inspection, and assembly processes in a general hands on approach.
- Gathers information for analysis to provide data on existing as well as proposed manufacturing, inspection, and assembly processes for good decision making This may include calculating production costs through labor, methods/processes, time, equipment, and materials.
- Works and collaborates with outside suppliers in acquiring information for new development requirements or in working through problems, issues, and/or challenges.
- Complies with regulations and established company policies, procedures, and processes to ensure best practices are followed that ensure all products or processes meet specifications and/or requirements.
- Attend or lead meetings as necessary as a part of team collaboration.
- Performs other duties as assigned.
- A minimum of 5 years of related industry experience is required.
- Design and development in regulated industries required, preferably medical device background and working knowledge of IEC 60601-x, ISO
- Experience with design controls for medical devices Title 21 CFR 820 and ISO 13485 is preferred.
- Experience with Risk Management ISO 14971 is preferred.
- Experience with Solidworks is required.
- Hands on experience with the design and development of small electromechanical systems/devices is preferred.
- Experience with BLDC motors, gearing design, battery enclosures, and dynamic sealing solutions is a plus.
- Must be familiar with Microsoft Project to schedule tasks, durations, with predecessor and successor relationships.
- Experience and general understanding of operation and programming of Computer Numerically Controlled (CNC) equipment is a plus.
- Experience with Design For Manufacturability/Inspection/Assembly (DFMIA).
- Good understanding of ASME Y14.5 Geometric Dimensioning & Tolerancing (GD&T) and how it relates to the design, manufacturing, inspection, and assembly processes or procedures.
- Able to conduct tolerance stack-up analysis is required.
- Able to conduct stress analysis or analysis of the loading conditions on a design.
- Able to understand and implement principles of Lean Methodology for improvements and gain efficiencies.
- Able to apply statistical methods to analyze data for testing, manufacturing, inspection, and assembly processes Able to gather information and data quickly and efficiently for analysis to provide direction and guidance for good decision making.
- Assume responsibility and ownership of assigned tasks with minimal direction and guidance.
- Exercise initiative and judgment with data driven decision making.
- Provide support to team members, customers, and others in the company as required.
- Assure all regulations, policies, procedures, or processes are followed as specified by the company.
- Utilize standards and best practices where appropriate.
- Maintain a safe working environment.
- Hands on approach to problem solving.
- Expected from time to time to put in extra time and
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Senior Mechanical Design Engineer - Garden Grove, United States - Professional Diversity Network
Description
Job Description:
We are seeking a Senior Mechanical Design Engineer for a very important client
JOB SUMMARY:
Works with and across the various disciplines of the engineering team, machine shop personnel, and assembly floor personnel for project realization, manufacturability, inspection, and assembly of product One of the primary functions of the position is to create and develop designs that meet product specifications and requirements.
JOB DUTIES:
Requirement:
effort to complete critical tasks to meet deadlines or objectives for the company.
The ideal candidate will possess the following qualifications:
SKILLS &
QUALS:
ACCOUNTABILITY:
Keywords:
Mechanical Design Engineer, Location:
Garden Grove, CA PDN-9aace82d-ef0b-447f-8f4e-c09615b8ea7b
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