R&D Engineer II

Job Description

Job Description

R&D Engineer IIWhat You’ll Be Part Of

You will be part of a dynamic product development team within a highly regulated medical device manufacturing environment. This organization focuses on developing complex, minimally invasive devices across multiple therapeutic areas, requiring precision engineering, strong process control, and strict compliance with regulatory standards.

You’ll collaborate with engineering, quality, manufacturing, and project teams to support the full product lifecycle—from early concept through commercialization. The environment is hands-on, fast-paced, and driven by innovation, technical rigor, and continuous improvement.

Why This Role Matters

This role plays a key part in executing product development programs and ensuring designs are translated into manufacturable, high-quality products. As an R&D Engineer II, you will contribute to both design and process development, helping bridge the gap between concept and production.

Your ability to execute engineering tasks independently, support validation efforts, and communicate technical progress ensures projects stay on track—meeting quality, timeline, and cost expectations.

What You’ll Do

• Design and develop medical devices from concept through production with moderate independence
• Support hands-on prototyping, assembly, and laboratory-based development activities
• Create and modify CAD models, components, tooling, and fixtures
• Build and evaluate prototypes to support design validation and iteration
• Develop and refine manufacturing processes, tooling, and assembly methods
• Support equipment setup, qualification, and basic maintenance activities
• Assist in process validation planning, feasibility assessments, and time studies
• Support transition of products from development into full-scale production
• Execute verification and validation activities, including testing and documentation
• Prepare and maintain engineering documentation such as test reports, drawings, and data analysis
• Ensure compliance with design control requirements and regulatory standards
• Support engineering changes and updates to existing products
• Communicate task status, risks, and technical challenges to project teams and leadership
• Support project execution by completing assigned deliverables on time and within scope
• Provide input on technical feasibility, scheduling, and potential risks
• Collaborate with suppliers and external partners on materials, components, and tooling
• Work cross-functionally with quality, manufacturing, supply chain, and project management teams
• Support investigations related to product issues, complaints, and process improvements

What We’re Looking For

• Experience in medical device engineering or a regulated manufacturing environment
• Proficiency in CAD software (SolidWorks or similar)
• Hands-on experience with prototyping and mechanical assembly
• Understanding of manufacturing processes and materials used in device production
• Familiarity with validation activities (IQ/OQ/PQ) and design controls
• Strong analytical and problem-solving skills
• Ability to work independently while collaborating across teams
• Strong communication skills for technical updates and cross-functional coordination
• Experience with catheter-based or complex device development is a plus

Education & Experience

• Bachelor’s or Master’s degree in Biomedical, Mechanical, or related engineering field
• 3+ years of experience in medical device development or regulated manufacturing

Physical Requirements

• Ability to work in laboratory, office, and manufacturing environments
• Frequent use of hands and tools for prototyping and testing
• Ability to sit, stand, and move between work areas as needed
• Ability to work at a computer workstation for extended periods

Benefits

Full health, dental, and vision benefits when offered by the employer
Paid time off and paid holidays available after a probationary period upon conversion to direct hire
Opportunities for technical growth and career advancement
Collaborative environment focused on innovation and product development

Equal Employment Opportunity

We are an Equal Employment Opportunity employer and do not discriminate based on race, color, religion, sex, national origin, age, disability, veteran status, or any other protected status under applicable law. All qualified applicants will receive consideration for employment without regard to any legally protected characteristics.