Performs production work in a light industrial and/or assembly environment within the guidelines of Tekna Inc. job description.
Utilize hand and power tools.
Ability to lift 20 lbs occasionally.
Staff members are crossed trained across multiple work stations, quality standards, as well as high standards of safety and workmanship.
Perform assembly activities with the direction of the line leader(s).
Assemble to written work instructions.
Assist in inspection of parts.
Strong verbal and written communication skills.
Reports to the Line Leader.
Senior Design Engineer – R&D
Senior Design Engineers are highly skilled in various engineering disciplines including but not limited to mechanical, electrical, and software engineering. Engineers design and develop products using complex scientific and mathematical techniques. The Senior Design Engineer creates engineering concepts that lead to detailed designs ensuring a product is safe, effective, efficient, reliable, and profitable through its intended life when used for its intended purpose. The Senior Design Engineer supports Consulting, New Product Development, and Production projects.
Provide engineering support to Consulting, New Product Development, and Production projects with limited oversight by the Project Manager and Lead Engineer.
Conduct customer, product, technical and regulatory research.
Establish and document Product Requirements for various stakeholders.
Develop conceptual designs utilizing 3D CAD software.
Conduct Intellectual Property analysis to protect the novelty of design and utility.
Conduct Architectural Analysis of the product to define the system, subsystem, and modular aspects of the design.
Design, develop, and prototype engineering solutions and participate in Design Reviews.
Apply the scientific method of observation, experimentation, and logical deduction to the analysis and solution of engineering problems.
Work with Supply Chain Management to source, quote, order, and receive goods and services necessary to create prototypes and evaluate designs.
Optimize design for manufacturing, inspection, and service as applicable.
Utilize 3D CAD software to produce accurate models, assemblies, and drawings.
Oversee Finite Element Analysis (FEA) and dimensional Stack Up Analysis.
Work with CAD Designers to create and release 2D drawings using appropriate drafting practices to show all detail necessary for the production of the design.
Work with Production Engineers in the creation of production fixtures and production assembly drawings.
Work with Industrial Designers in the creation of literature and labeling.
Work with Quality Engineers in the execution of PPAP.
Work with Production Engineers to qualify the manufacturing process and execute Pilot Production.
Plan and execute Product Verification & Validation efforts to include writing test reports and conducting tests.
Implement corrective action to solve design challenges or issues. This may include changing design features, selecting a different manufacturing method or a complete redesign of the component. At the extreme, this may require developing new concepts.
Work closely with coworkers and vendors to ensure those project goals are met and completed on schedule.
Assist the Project Manager and Lead Engineer to ensure that all required design control documentation is completed, and all quality requirements have been met.
Provide post-release manufacturing support for product improvements, documentation updates (DCN’s), engineering updates (ECN’s), and cost reductions.
Display a professional image and positive attitude to coworkers and customers alike.
Key Abilities (competency that affects product quality)
Bachelor of Science in Engineering to include but not limited to mechanical, electrical, and software engineering.
Tekna requirements for Document Control (PROC001)
Tekna requirements for Design Control (PROC010)
Tekna requirements for Risk Management (PROC024)
Tekna requirements for Supplier Control (PROC029)
Experience: 2 to 3 years of successful experience as a Design Engineer
Ability to mentor and train entry-level Design Engineers
Exercise original thought and judgment
Work in a group environment with creative, open-minded, out of the box thinking
Possess strong math and computer skills
Have a creative flair and design ability
Demonstrate visual and spatial awareness
Show attention to detail
Manage time and organize tasks
Exhibit sound knowledge of engineering design principles
Possess good communication skills
Have a good knowledge of material properties
Understand manufacturing processes and construction methods
Exhibit Good problem-solving skills
Demonstrate the ability to meet deadlines
This position’s activities are relevant and important because:
Document Control – this is how documents are controlled (ISO 13485:2016 4.2.4, 21CFR 820.40)
Design Control – this is how requirements for the development of products are established (ISO 13485:2016 7.3, 21CFR 820.30)
Risk Management – this is how risk is planned, assessed, and controlled for products (ISO 13485:2016 7.3.3, 21CFR 820.30, ISO 14971)
Supplier Control – this is how requirements for suppliers are established and how they are monitored (ISO 13485:2016 7.4, 21CFR 820.50)
This position’s activities contribute to the achievement of the quality objectives by:
Ensuring control of quality documents and records.
Ensuring product requirements are correctly established, verified and translated to production.
Ensuring the risk of products is assessed and controlled appropriately.
Ensuring suppliers can provide components as specified