As a Senior R&D Manufacturing Engineer at DEKA, you'll play a critical role in transforming innovative medical device and disposable designs into scalable, high-quality, and regulatory-compliant manufacturing solutions. You'll work at the intersection of R&D engineering, design, quality, and supply chain to ensure our products are not only manufacturable, but meet the stringent demands of safety, reliability, and performance required in healthcare.
You'll lead detailed DFM reviews, evaluate GD&T and component specifications, and guide new product introductions from prototyping through to full-scale production at external manufacturing resources. Your expertise in manufacturing medical consumables-including molded parts, film weldments, packaging, and labeling -will help bring life-changing technologies to market efficiently and cost-effectively.
From collaborating on DFMEA/PFMEA, managing prototype builds, and optimizing supplier strategies, to developing ROI-backed launch plans and driving continuous improvement-you'll make a direct impact on how we deliver breakthrough medical solutions to patients around the world.
How you will make an impact as a Manufacturing Engineer:
- Evaluating and understanding of the design intent, manufacturability, GD&T of components and assemblies specs for transition into the mass production.
- Reviewing design documents and Specification and working with the design team to finalize them
- Detailed assessments and critical DFM review of engineering designs/drawings/specifications of components and assemblies.
- Providing analysis and recommendations for feature and manufacturing cost tradeoffs, during the design phase.
- Identify the manufacturing technologies relevant to new design concepts, advise the design team on the best and effective means to execute.
- Identifying improvements and drive actions back to design or advancing process working with the sourcing team at the supplier or tooling improvements
- Evaluating and finalizing inspection and test requirements
- Working with the sourcing team to develop strategy for these designs and provide estimates or review quotes of cost, and tooling required to execute.
- Working with the sourcing team to develop comprehensive, cost effective manufacturing strategies, including supplier selection, to drive product team decisions on sourcing to achieve cost targets.
- Working with design team and suppliers on DFMEA, PFMEA, risk analysis
- Develop manufacturing cost models to feed advisory information to the design teams
- Working with CM and to drive quality and cost
- Evaluating and finalizing on a scaled launch approach for designs concepts. Matching time and concepts to execute with appropriate maturity of design. Ex. Machined approach to start thru to a tooled approach in later time.
- Manage this maturity and progression thru to full execution, including ROI justifications.
- Managing the manufacturing of prototypes used in new product development, including selecting the most appropriate prototype methods and executing prototype development to support new product design trials.
- Conceive, design, develop, implement fixtures, jigs, and automation equipment for prototype and production line.
To be successful in this role you will need to the following skills:- BS Degree in Mechanical Engineering or similar with Manufacturing focus
- 5+ years in a manufacturing engineering role which includes NPI or CM experience.
- Experience manufacturing medical disposables at scale, including injection molding, welding, films, flexures, inserts/overmolds, packaging, and labeling. Experience taking a product from initial concept to launch and scale.
- Design skills including GD&T, design validation, and inspection.
- Demonstrated Solidworks proficiency.
- Experience in should-cost analysis and models to evaluate Cost of Goods
- Experience with Six Sigma tools and Lean Manufacturing concepts.
