R-D Engineer II

Pay 40-50/h depending on experience

HM’s Top Needs:

• 1. Experience with lab equipment/test method development
• 2. Strong technical skills, including root cause investigation, CAD (Solid Works) 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)
• Years’ Experience
  
  Required:
  
  2+ years

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.

This role is an individual contributor within the Interventional Cardiology Therapies.

• 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.

• Bachelor’s Degree in Engineering (Mechanical or Biomedical, Materials, Chemical)
• 2+ years of experience

• 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).

• Master’s degree.
• Experience with test method validation.
• Knowledge of design of experiments (DOE) and statistical techniques.
• Experience with structural heart catheter products, processing and technologies
• Experience with failure analysis, process improvements and change management
• Strong problem-solving capabilities