Senior Medical Device Manufacturing Engineer - NPI & DFMEA

deka; Richmond (NH); On-site; USD 90,000 - 120,000; Full time

Job summary

DEKA is seeking a Senior R&D Manufacturing Engineer to transform innovative medical device concepts into scalable, compliant manufacturing solutions. You will lead DFM reviews, evaluate GD&T, and guide NPI from prototyping to full production with external CM resources.

You will collaborate across design, quality, and supply chain, develop cost models, and drive continuous improvement in molding, film, packaging, and labeling. Domestic candidates in NH region preferred.

Qualifications

• BS Degree in Mechanical Engineering or similar with Manufacturing focus
• 5+ years in a manufacturing engineering role including NPI or CM experience
• Experience manufacturing medical disposables at scale (injection molding, welding, films, packaging, labeling)
• Design skills including GD&T, design validation, and inspection
• Demonstrated SolidWorks proficiency
• Experience in should-cost analysis and cost of goods models
• Experience with Six Sigma tools and Lean Manufacturing concepts

Responsibilities

• Evaluating and understanding of the design intent, manufacturability, GD&T of components and assemblies specs for transition into mass production
• Reviewing design documents and specifications and working with the design team to finalize them
• DFM reviews of engineering designs/drawings/specifications of components and assemblies
• Providing analysis and recommendations for features and manufacturing cost tradeoffs during the design phase
• Identify manufacturing technologies relevant to new design concepts and advise on execution
• Develop supplier strategies and cost/tooling estimates with sourcing
• Develop and finalize inspection and test requirements
• Develop comprehensive, cost-effective manufacturing strategies including supplier selection
• Work with design teams on DFMEA and PFMEA risk analysis
• Develop manufacturing cost models to guide design decisions
• Work with CM to drive quality and cost
• Finalize scaled launch approaches matching maturity of design
• Manage prototype manufacturing and ROI justifications
• Conceive, design, and implement fixtures, jigs, and automation for prototype and production

Skills

DFM reviews

GD&T

DFMEA/PFMEA

SolidWorks

Cost modeling

Lean/Six Sigma

Education

B.S. Mechanical Engineering

Tools

SolidWorks

Job description

DEKA is seeking a Senior R&D Manufacturing Engineer to transform innovative medical device concepts into scalable, compliant manufacturing solutions. You will lead DFM reviews, evaluate GD&T, and guide NPI from prototyping to full production with external CM resources.

You will collaborate across design, quality, and supply chain, develop cost models, and drive continuous improvement in molding, film, packaging, and labeling. Domestic candidates in NH region preferred.