R-D Engineer II

Planet Pharma; Santa Rosa (CA); On-site; USD 55,000 - 69,000; Full time

Job summary

Planet Pharma in Santa Rosa, CA is seeking an R&D Engineer II to design, develop and launch medical devices within Interventional Cardiology Therapies. You will collaborate with Clinical, Manufacturing, Quality and Regulatory teams to deliver robust products.

Responsibilities include designing and prototyping mechanical components, leading root-cause investigations, creating CAD models and drawings, and performing protocol-based testing (DV, Dval, lot release).

Qualifications

• Bachelor’s degree in Engineering as stated.
• 2+ years of experience required.

Responsibilities

• Design, develop and launch medical devices with the team.
• Analyze, troubleshoot and provide technical skills during research and trials.
• Collaborate with Clinical, Manufacturing, Quality, Marketing, Regulatory Affairs and other key functions.
• Design, develop structural heart medical device products and processes.
• Create CAD components, assemblies or drawings and lead root cause investigations.
• Perform protocol-based testing (DV, Dval, lot release).
• Document research and development process through lab notebooks and test reports.
• Support early-stage design controls leading to pilot line that is scalable.

Skills

Lab equipment/test method development

Root cause investigation

CAD (SolidWorks) design

Technical drawing

Protocol-based testing (DV, Dval, lot)

Education

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

Tools

SolidWorks

Job description

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 (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)
• 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.

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).

Nice to have

• 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