Senior R&D Manufacturing Engineer - Disposables

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 will 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 will 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 will make a direct impact on how we deliver breakthrough medical solutions to patients around the world.

• Evaluate design intent, manufacturability, GD&T of components and assemblies for transition into mass production.
• Review design documents and specifications and work with the design team to finalize them.
• Conduct detailed assessments and critical DFM review of engineering designs/drawings/specifications of components and assemblies.
• Provide analysis and recommendations for feature and manufacturing cost tradeoffs during the design phase.
• Identify manufacturing technologies relevant to new design concepts, advising the design team on the best and effective means to execute.
• Identify improvements and drive actions back to design or advance process working with the sourcing team at the supplier or tooling improvements.
• Evaluate and finalize inspection and test requirements.
• Work with the sourcing team to develop strategy for these designs and provide estimates or review quotes of cost, and tooling required to execute.
• Develop comprehensive, cost‑effective manufacturing strategies, including supplier selection, to drive product team decisions on sourcing to achieve cost targets.
• Collaborate with design team and suppliers on DFMEA, PFMEA, risk analysis.
• Develop manufacturing cost models to feed advisory information to the design teams.
• Work with CM to drive quality and cost.
• Evaluate and finalize a scaled launch approach for design concepts, matching time and concepts to execute with appropriate maturity of design (e.g., machined approach to start through to a tooled approach in later time).
• Manage this maturity and progression through to full execution, including ROI justifications.
• Manage 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, and implement fixtures, jigs, and automation equipment for prototype and production line.

• BS Degree in Mechanical Engineering or similar with a manufacturing focus.
• 5+ years in a manufacturing engineering role that 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 Solid Works proficiency.
• Experience with should‑cost analysis and models to evaluate cost of goods.
• Experience with Six Sigma tools and Lean Manufacturing concepts.