Research And Development Engineer II

Sponsorship for employment visas is NOT available for this position (e.g., H-1B, OPT/CPT stem extensions, STEM OPT extension). Applicants must be currently authorized to work in the United States on a full-time basis.

Company Overview:

Our client is a global leader in medical technology that researches, designs, and manufactures healthcare devices.

Role Summary

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 Client’s Interventional Cardiology Therapies.

Key Responsibilities

• 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 methods, 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.

Required Qualifications

• Bachelor’s degree in Engineering (Mechanical, Biomedical, Materials, or Chemical).
• 2+ years of R&D, Quality, or Manufacturing experience in a regulated industry (medical device preferred).
• Strong 3D modeling, assembly, and drafting skills in SolidWorks.
• Applied knowledge of statistical techniques (tolerance intervals, normality testing, t-tests) using tools like Minitab.
• Proven ability to independently drive root cause investigations and implement practical technical solutions.
• Strong technical writing and verbal skills with a self-motivated drive to execute tasks under general direction.

Preferred Qualifications

• Hands-on experience with structural heart catheter products, materials, or processing technologies.
• Track record with Test Method Validation (TMV), Design of Experiments (DOE), and process improvement frameworks.
• Experience supporting early-stage design controls for First-in-Human (FIH) clinical studies.

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