Qureos Mentor

Deka Research & Development

<div>As a Senior Manufacturing Engineer at DEKA, you&rsquo;ll play a critical role in transforming innovative medical device designs into scalable, high-quality, and regulatory-compliant manufacturing solutions. You&rsquo;ll work at the intersection of 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&rsquo;ll lead detailed DFM reviews, evaluate GD&amp;T and component specifications, and guide new product introductions from prototyping through to full-scale production. Your expertise in manufacturing electro-mechanical assemblies&mdash;including machined, molded, cast, and PCBA components&mdash;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&mdash;you&rsquo;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:<ul><li>
Evaluating and understanding of the design intent, manufacturability, GD&amp;T of components and assemblies specs for transition into the mass production.</li><li>
Reviewing design documents and Specification and working with the design team to finalize them</li><li>
Detailed assessments and critical DFM review of engineering designs/drawings/specifications of components and assemblies.</li><li>
Providing analysis and recommendations for feature and manufacturing cost tradeoffs, during the design phase.</li><li>
Identify the manufacturing technologies relevant to new design concepts, advise the design team on the best and effective means to execute.</li><li>
Identifying improvements and drive actions back to design or advancing process working with the sourcing team at the supplier or tooling improvements</li><li>
Evaluating and finalizing inspection and test requirements</li><li>
Working with the sourcing team to develop strategy for these designs and provide estimates or review quotes of cost, and tooling required to execute.</li><li>
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.</li><li>
Working with design team and suppliers on DFMEA, PFMEA,</li><li>
Develop manufacturing cost models to feed advisory information to the design teams</li><li>
Working with CM and to drive quality and cost</li><li>
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.</li><li>
Manage this maturity and progression thru to full execution, including ROI justifications.</li><li>
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.</li><li>
Conceive, design, develop, implement fixtures and jigs for prototype and production line.</li></ul> 

To be successful in this role you will need to the following skills:<ul><li>
BS Degree in Mechanical Engineering or similar with Manufacturing focus</li><li>
5+ years in a manufacturing engineering role which includes NPI or CM experience.</li><li>
Experience manufacturing electro mechanical products at scale, including machined, cast, forged, PCBA and cables and plastic components.</li><li>
Experience, taking a product from launch to scale</li><li>
Design skills including GD&amp;T, design validation, and inspection.</li><li>
Demonstrated Pro-E/Creo and or Solidworks proficiency.</li><li>
Experience in should-cost analysis and models to evaluate Cost of Goods</li><li>
Experience with Six Sigma tools and Lean Manufacturing concepts.</li></ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research &amp; Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA&rsquo;s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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Senior Manufacturing Engineer

<div>DEKA Research &amp; Development, located in Manchester, NH, is seeking an Product Development Engineering Lead. In this role, you will drive new product development teams to deliver highly innovative products and solutions in autonomous robots, medical devices, or other devices that improve the lives of others. You will lead by example and have ownership of managing highly complex, technical projects encompassing a diverse group of engineering talent. As the lead for the project, you will interface with world-class corporate partners to understand high-level project goals, translate them into technical requirements, and lead a team to invent, design, develop and transition products to manufacturing. 
 
How you will make an impact as an Product Development Engineering Lead at DEKA:<ul><li>
Lead a cross-functional technical team through V&amp;V, clinical trials and commercialization</li><li>
Translate high-level project goals into system requirements; working with both internal and external project stakeholders</li><li>
Provide both high-level technical and people leadership to project teams</li><li>
Drive delivery of aggressive goals while managing project schedule, cost, and resources effectively</li><li>
Interface with customers and manage relationships to ensure crisp communication and alignment of objectives</li><li>
Drive day-to-day project activity to achieve results including removing roadblocks to solving technical and other project challenges, managing resource conflicts, upholding high-performance standards, and meeting commitments</li><li>
Create comprehensive project plans</li><li>
Work closely with upper management to drive project schedules and resolve roadblocks across all DEKA projects</li></ul>
To be successful in this role, you will need the following skills and experience:<ul><li>
Bachelor&rsquo;s Degree in an engineering discipline with a minimum of 5 years leading medical device product development teams solving challenging technical projects</li><li>
Experience with taking Class III medical devices through clinical trials</li><li>
Experience with electromechanical products with embedded software</li><li>
Direct experience leading projects from initial concept through design and release</li><li>
Must have experience successfully managing schedule, budget, and project resources</li><li>
Exceptional project management and communication skills (both written and verbal)</li><li>
High energy, drive, commitment, self-initiative, and perseverance are required with a demonstrated track record</li></ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA&rsquo;s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored.
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Product Development Engineering Lead

<div>DEKA Research &amp; Development has an immediate opening for a Biocompatibility &amp; Toxicology Senior Scientist to join our team focused on medical device and combination product development. The individual in this role will work directly with Research &amp; Development, Regulatory &amp; Clinical Affairs and Quality Engineering to formulate and execute biocompatibility and toxicological evaluation strategies that support development objectives and world-wide regulatory approvals. 
 
How you will make a difference as a Biocompatibility &amp; Toxicology Senior Scientist:<ul><li>
Work in close association with customers and development teams to define and execute biocompatibility/toxicology evaluations, including establishing requirements for biological safety of medical devices and combination products</li><li>
Lead the preparation and conduct of biocompatibility/toxicology test programs</li><li>
Lead interactions with external consultants and contract laboratories including in-person meetings, teleconferences, and other communications as needed to support program objectives</li><li>
Develop and deploy mechanisms to continually maintain state of the art knowledge and understanding related to biocompatibility and toxicological safety of medical devices, including relevant standards and test methods. Insure processes and procedures maximize resource efficiency and minimize time to market</li><li>
Insure the organization stays up to date on global regulatory changes to medical device biocompatibility standards and requirements through monitoring regulatory authority and industry resources</li><li>
Coach and mentor internal and external partners on effective strategies and tactics</li><li>
Interface with customers on biocompatibility and toxicology issues</li></ul>
Skills you will need to be successful:<ul><li>
MS in a technically related field (toxicology, materials science, chemical engineering, biomedical engineering or related).</li><li>
Minimum of 7 years direct work experience in a medical device and/or combination product development role with demonstrated success in planning and conducting biocompatibility and toxicological evaluations</li><li>
Expertise in U.S. and international medical device biocompatibility requirements including ISO 10993 standards, Good Laboratory Practices, and guidance from regulatory authorities</li><li>
Demonstrated practical knowledge of the laboratory methods and analytical techniques associated with medical device and/or combination product biocompatibility and chemical characterization evaluations</li><li>
Demonstrated ability to establish consensus and work collaboratively across functions and development teams</li><li>
Excellent written and verbal communication skills including the ability to effectively communicate at all levels of the organization and with external partners</li></ul>
About DEKA:
One hour from the beach, Boston, and the mountains, the historic Amoskeag Millyard once housed the largest textile mills in the world. It is now home to DEKA Research and Development, where we are taking the same innovation and cutting-edge technology into the modern age.
Behind DEKA&rsquo;s brick walls sits a team of professionals who strive to make a difference every day through thoughtful engineering, design, and manufacturing. Here at DEKA, some of the most innovative and life-changing products of our time are created, and new ideas are always welcome and explored. 

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Biocompatibility & Toxicology Senior Scientist

Join Deka Research & Development and explore 3   exciting career opportunities. They're hiring for various roles with options for remote or on-site work. Apply today and become part of their innovative team.

Deka Research & Development

ABOUT_COMPANY

Senior Manufacturing Engineer

Product Development Engineering Lead

Biocompatibility & Toxicology Senior Scientist