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Infotree Global Solutions

27 jobs near Columbus, OH

Infotree Global Solutions

Material Handler 1 I

Worcester, MA · On-site

$16.75 - $20.25/hr

Description: • Must be able to lift 35lbs up to 50lbs consistently. • Must have at least one year (1) of experience operating fork trucks, strongly preferring stand-up fork truck experience. • ...

Infotree Global Solutions

Call Center Agent I

Galesburg, MI · On-site

$14 - $18.50/hr

Description: The primary function of the Customer Experience Representative (CER) will provide warranty support, direct and adjudicate product warranty repairs via phone and electronic communication ...

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Senior Research And Development Engineer (Medical Devices)

Infotree Global Solutions

Santa Rosa, CA • On-site

$114K - $156K/yr

Other

Posted 5 days ago

Job description

R&D Engineer (Medical Devices) || Santa Rosa, CA

12+ months


HM's Top Needs:

1. Experience with lab equipment/test method development

2. Strong technical skills, including root cause investigation, CAD (SolidWorks) part design, assemblies, technical drawing

3. Familiar with protocol-based testing (DV, Dval, lot release, etc.)

Education Required: Bachelor’s degree in Engineering (Mechanical or Biomedical, Materials, Chemical)




The R&D Engineer II works collaboratively with a team to design, develop and launch medical devices as well as support existing products. Responsibilities include design & development of structural heart medical device products and processes. This position may analyze, troubleshoot and provide technical skills during research, product development and/or clinical trials. This position requires collaborative interaction with Clinical, Manufacturing, Quality, Marketing, Regulatory Affairs and other key functions to achieve business deliverables.

· Designs, develops, analyzes, troubleshoots and provides technical skills during research and/or product development.

  • Work independently and in a team environment, including lab environment.
  • Develop test mentods, lead root cause investigations, create CAD components, assemblies or drawings.
  • Perform protocol-based testing, for example, DV, DVal, lot release, etc.
  • Prototype, test, and iterate designs used in the medical field
  • Support the development and integration of new technologies into product offering.
  • Document research and development process through lab notebooks, engineering characterization studies, and test reports.
  • Take an active role in early-stage design control activities leading to a first in man study (innovation, proof of principle, product development, process development, and equipment development) such that a robust pilot line that is scaleable and transferable to commercial manufacturing is achievable.
  • Work with Regulatory Affairs (RA) to compile US and OUS regulatory submissions. Assist RA with answering subsequent questions from regulatory bodies.
  • Design and develop new test methods and equipment specific to new products. Train technicians in new processes.
  • Create document change orders (CO’s) for design, materials, and process documentation.
  • Work with Regulatory, Preclinical, Quality, and Manufacturing departments to create product performance, design, and manufacturing specifications.
  • Interact frequently with all departments within organization and occasionally with external physicians, consultants, and vendors.


Basic Qualifications:

· Bachelor’s Degree in Engineering (Mechanical or Biomedical, Materials, Chemical)

· 2+ years of experience

Required Job Competencies:

· Experience in R&D, Quality and/or Manufacturing in a regulated industry, working through different phases of product development.

· Prototyping mechanical components and systems.

· Complete understanding and wide application of technical principles, theories, and concepts toward product, process, and technology development and evaluation.

· Able to provide imaginative, thorough and practical technical solutions to a wide range of difficult problems, consistent with company’s objectives.

· Successful collaboration as part of a cross-functional team.

· Background demonstrating strong self-motivation; able to works under only general direction, independently determining and developing approaches to solutions.

· Proficient with computer applications (i.e. Word, Excel, PowerPoint, Minitab, etc.).

· Ability to communicate well (both written and verbal).


Thanks & Regards,

Raman Sharma

Team Lead

Direct no : 734-228-1968

rsharma@infotreeglobal.com

Infotree Global Solutions

www.infotreeglobal.com

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