Sr Mechanical Design Engineer
4620 North Beach Street Haltom City, TX 76137 US
Job Description
TopĀ technicalĀ skills that you are looking for in a candidates experience:
- Proficient in the use of PTC-Creo or SolidWorks.
- Extensive knowledge in the design of machined components including understanding and evaluation of CTQs/EDO
- Experience with applying GD&T principles and performing complex Tolerance Stack analysis
- Experience working with internal and/or external component suppliers
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Education Required: Ā Bachelors or higher in Mechanical Engineering
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Yearsā Experience Required: 4+ yrs
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As a Senior Engineer, you are a member of the Supplier Optimization organization through theĀ Supplier Transfer Optimization Program (STOP), an initiative to significantly optimize our supply base in our direct materials supply base. You will have specific responsibilities for the design, development, implementation and transfer of products used in the medical device space. The role of the Senior R&D engineer requires strong technical and leadership skills and will apply advanced technical principles, theories, and concepts in working on complex technical problems.Ā Ā The Senior Engineer will play a key technical leadership role in development projects from concept through commercialization and act as the primary technical lead for these programs.
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Responsibilities may include the following and other duties may be assigned.
- Collaborate with the cross functional team for ā Supplier selection, Component qualifications, Development of inspection methods & Inspection fixtures.
- Support internal and external component sourcing/transfer efforts
- Evaluate the impact of design changes and dimensional changes on product functionality, performance & reliability
- Provides engineering support and technical leadership for new product design and development, existing product modifications, and/or process design, development and improvement, and performance evaluation.
- Support QE in development of inspection methods and GR&R studies (basic understanding of inspection methods, terminology and sampling plans)
- Uses computer-assisted engineering and design software and equipment to perform engineering and design tasks.
- Develops and tests prototypes from design specifications, defines processes to properly make and assemble the product and optimizes process.
- Develops product and process verification and validation, test protocols and reports in compliance with design control requirements.Ā
- Analyzes test data and reports to determine if designs meet functional and performance requirements.
- Champion new ideas by presenting to and influencing peers and upper management.
- Provide high-level technical input supporting submissions to regulatory bodies and governmental agencies.
- Review and approve engineering change orders for design, materials, and process documentation.
- Create product performance, design, and process specifications.
- Interfacing with the Biocompatibility/Toxicology SMEs to complete biocompatibility assessment
- Ensure all activities follow the company Code of Conduct and all Quality System Requirements.
Must Have: Minimum Requirements
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Bachelors degree required
Minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience
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- Ability to perform detailed tolerance stack-up analysis of precision assemblies.
- Advanced understanding and application of GD&T (Geometric Dimensioning and Tolerancing).
- Experience with product testing, including test protocol/report writing
- Experience with Supplier Transfer, component qualifications, component inspection methods
- Product design, development, changes and improvements
Nice to Have
- Proficient in the use of PTC-Creo or SolidWorks.
- Extensive knowledge in the design of machined components including understanding and evaluation of CTQs/EDOs
- Experience with applying GD&T principles and performing complex Tolerance Stack analysis
- Experience working with internal and/or external component suppliers
- Demonstrated experience collaborating with cross functional team including quality, manufacturing and regulatory
- Medical device industry experience
- Demonstrated proficiency in the field of mechanical engineering.
- Demonstrated ability to effectively manage complex projects.
- Demonstrated ability to solve complex problems in creative and effective ways.
- Demonstrated excellent interpersonal skills.
- Demonstrated excellent organizational skills.
- Demonstrated excellent verbal and written communication skills including ability to effectively develop and present complex technical information necessary for the company.
- Demonstrated excellent analytical skills.
- Demonstrated advanced team leadership skills
- Proficient with personal computer software including word processing, spreadsheet, and statistical programs; computer aided drawing and project scheduling software preferred
- Demonstrated advanced understanding and application of Quality System requirements, including FDA GMPs, and ISO 9000 and documentation procedures; ability to learn MPSM systems quickly
- Engineering statistical data analysis using Minitab, Six Sigma, A3/Fishbone/DRM, etc.
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