R-D Engineer II

12-month contract with potential for extension in Santa Rosa, CA. W2 contract; no PTO or benefits. ACA-compliant supplemental package available for enrollment. Candidates must be legally authorized to work in the United States and able to sit on Primary Talent Partners W2 without sponsorship.

About the role

The R&D Engineer II works collaboratively with a team to design, develop, and launch medical devices as well as support existing products. This role is an individual contributor within Healthcare's Interventional Cardiology Therapies.

Responsibilities

• Design and develop structural heart medical device products and processes.
• Analyze, troubleshoot, and provide technical skills during research, product development, and/or clinical trials.
• Collaborate with Clinical, Manufacturing, Quality, Marketing, Regulatory Affairs, and other key functions to achieve business deliverables.
• Design, develop, analyze, troubleshoot, and provide technical skills during research and/or product development.
• Work independently and in a team environment, including lab settings.
• Develop test methods, lead root cause investigations, and create CAD components, assemblies, or drawings.
• Perform protocol-based testing (e.g., DV, DVal, lot release).
• Prototype, test, and iterate designs used in the medical field.
• Support the development and integration of new technologies into product offerings.
• 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-human study (innovation, proof of principle, product development, process development, and equipment development) to ensure a robust pilot line that is scalable and transferable to commercial manufacturing.
• 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 the organization and occasionally with external physicians, consultants, and vendors.

Requirements

• Bachelor's Degree in Engineering (Mechanical or Biomedical, Materials, Chemical).
• 2+ years of experience in R&D, Quality, and/or Manufacturing in a regulated industry, working through different phases of product development.
• Experience 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 objectives.
• Successful collaboration as part of a cross-functional team.
• Strong self-motivation; able to work under only general direction, independently determining and developing approaches to solutions.
• Proficient with computer applications (e.g., Word, Excel, PowerPoint, Minitab).
• Strong written and verbal communication skills.

Skills

• Must Have:
  • Root cause investigation.
  • Ability to work independently and in a team environment.
  • CAD (SolidWorks) part design, assemblies, and technical drawing.
  • Statistical tools (tolerance interval, normality, t-test).
• Nice to Have:
  • Experience with lab equipment/test method development.
  • Technical writing (protocols/reports, complaint reports, etc.).
  • Familiarity with protocol-based testing (DV, DVal, lot release, etc.).
  • 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.

Pay

$45.00 - $55.00/hr

Schedule

12-month contract with potential for extension.