Senior Medical Device R&D Engineer Breakthrough

Cresilon; New York, Northern (NY, KY); Hybrid; USD 100,000 - 160,000; Full time

Benefits offered by this job

Competitive salary

Vacation & holidays

Health insurance

401(k) retirement plan

MetroCard reimbursement

Life insurance

Employee assistance program

Job summary

Cresilon, a Brooklyn-based biotechnology and medical device company, is seeking a Senior Medical Device R&D Engineer to lead design and development of new products and improve existing ones. You will author documents under Design Control, support supplier reviews, and perform data generation through designed experiments.

The role emphasizes hands-on prototype design, testing, and collaboration across regulatory, manufacturing, and marketing teams in a fast-paced environment.

Qualifications

• BS in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering, or related scientific discipline.
• A minimum of 5+ years of product development experience is required.
• A minimum of 4 years of hands-on experience in new product research and development in a cGMP-regulated industry (medical device preferred).
• Experience with designing and testing medical devices and their safety/efficacy characterization.

Responsibilities

• Create and lead experimentation for exploratory and/or product development research focusing on polymeric materials devices and their use.
• Define new product functional requirements and evaluate the design's overall effectiveness, cost, reliability, and safety.
• Lead cross-functional teams to develop new products, address design issues, and maintain existing designs.
• Apply strong problem-solving skills to find solutions to complex problems.
• Work independently to plan and schedule activities to meet project timelines.
• Interface with customers, suppliers, and internal cross-functional team members to develop specifications and coordinate prototype fabrication.
• Develop and execute test methods, including GLP/GMP documentation and ISO 13485 alignment.

Skills

Experimental design

Data analysis

Cross-functional leadership

Problem solving

Regulatory knowledge

Education

Bachelor's degree in Chemical Engineering, Polymer Engineering, Material Science, Biomedical Engineering, Mechanical Engineering

Tools

SolidWorks

Excel

Word

PowerPoint

Job description

Cresilon, a Brooklyn-based biotechnology and medical device company, is seeking a Senior Medical Device R&D Engineer to lead design and development of new products and improve existing ones. You will author documents under Design Control, support supplier reviews, and perform data generation through designed experiments.

The role emphasizes hands-on prototype design, testing, and collaboration across regulatory, manufacturing, and marketing teams in a fast-paced environment.