Highlander Consultants Inc Defunct
24th September, 2025
Medical Device Design Engineers
Highlander Consultants
Jacksonville, Florida, United States (100% On-site)
We have multiple R&D / Product Design Engineering opportunities open at various skill levels. We are seeking passionate Design Engineers who want to be 100% onsite working on their craft with the R&D / NPD team!
Product Development R&D Engineer - Medical Device
Position Summary The Product Development (Research and Development) Engineer has a
passion for design
and would be responsible for driving the design, development, and commercialization of innovative medical devices. This role encompasses both hands-on technical innovation and cross-functional project leadership, ensuring products meet clinical needs, regulatory requirements, and quality standards.
Key Responsibilities Lead new product development:
Guide projects from concept through manufacturing transfer, including ideation, prototyping, verification, and validation. Design & innovation:
Develop and refine device designs based on user requirements, market needs, and clinical input. Use 3D CAD tools for modeling and drafting. Project leadership:
Oversee project timelines, resources, and deliverables for high-complexity development programs; provide technical mentoring to junior engineers. Cross-functional collaboration:
Work with clinical, marketing, regulatory, manufacturing, and quality teams to ensure product success and compliance. Risk management:
Assess and mitigate technical and project risks throughout the product lifecycle. Testing & validation:
Develop and execute test methods, verification, and validation plans aligned with regulatory and quality system requirements. Documentation:
Prepare and maintain comprehensive technical, regulatory, and design history documentation. Process improvement:
Identify and implement opportunities for development process, manufacturing, and product performance optimization. Regulatory compliance:
Ensure all development activities comply with FDA, ISO, and related medical device regulations. Continuous learning:
Stay updated with advances in medical device technologies, processes, and regulations. Required Qualifications
Education:
Bachelor's degree in Engineering (Mechanical, Biomedical, or related field) required; Master's degree preferred. Experience:
Minimum 3-5 years of medical device product development or R&D experience, including experience with design transfer and regulatory submissions. Technical Skills:
Proficient in CAD (e.g., SolidWorks), design controls, and device lifecycle management. Design for manufacturing - we have a 3D printing lab and CNC machinery for prototype development Understanding of materials science and manufacturing processes. Expertise in design verification/validation and risk management. Soft Skills: Strong project management, organizational, and analytical skills. Excellent communication skills for technical writing, reporting, and cross-team collaboration. Ability to lead and mentor, as well as work independently or in teams. Preferred Skills & Attributes
Experience in clinical investigations and product commercialization. Demonstrated record of technical innovation and product launches. Experience with regulatory bodies (FDA, ISO, CE), risk assessment, and quality systems. Hands-on experience with prototyping and manufacturing scale-up. Benefits
Opportunity to work on groundbreaking medical technologies that improve patient outcomes. Competitive salary, bonus eligibility, and promotionwe are growing! Professional development and cross-functional networking in a high-performing, innovative and hands-on environment. Exposure to international clinical leaders, state-of-the-art labs, and global medical device markets. This job offers a dynamic role for engineers ready to lead and innovate in the medical device Design field, making a tangible impact on patient health and safety
Medical Device Design Engineers
Highlander Consultants
Jacksonville, Florida, United States (100% On-site)
We have multiple R&D / Product Design Engineering opportunities open at various skill levels. We are seeking passionate Design Engineers who want to be 100% onsite working on their craft with the R&D / NPD team!
Product Development R&D Engineer - Medical Device
Position Summary The Product Development (Research and Development) Engineer has a
passion for design
and would be responsible for driving the design, development, and commercialization of innovative medical devices. This role encompasses both hands-on technical innovation and cross-functional project leadership, ensuring products meet clinical needs, regulatory requirements, and quality standards.
Key Responsibilities Lead new product development:
Guide projects from concept through manufacturing transfer, including ideation, prototyping, verification, and validation. Design & innovation:
Develop and refine device designs based on user requirements, market needs, and clinical input. Use 3D CAD tools for modeling and drafting. Project leadership:
Oversee project timelines, resources, and deliverables for high-complexity development programs; provide technical mentoring to junior engineers. Cross-functional collaboration:
Work with clinical, marketing, regulatory, manufacturing, and quality teams to ensure product success and compliance. Risk management:
Assess and mitigate technical and project risks throughout the product lifecycle. Testing & validation:
Develop and execute test methods, verification, and validation plans aligned with regulatory and quality system requirements. Documentation:
Prepare and maintain comprehensive technical, regulatory, and design history documentation. Process improvement:
Identify and implement opportunities for development process, manufacturing, and product performance optimization. Regulatory compliance:
Ensure all development activities comply with FDA, ISO, and related medical device regulations. Continuous learning:
Stay updated with advances in medical device technologies, processes, and regulations. Required Qualifications
Education:
Bachelor's degree in Engineering (Mechanical, Biomedical, or related field) required; Master's degree preferred. Experience:
Minimum 3-5 years of medical device product development or R&D experience, including experience with design transfer and regulatory submissions. Technical Skills:
Proficient in CAD (e.g., SolidWorks), design controls, and device lifecycle management. Design for manufacturing - we have a 3D printing lab and CNC machinery for prototype development Understanding of materials science and manufacturing processes. Expertise in design verification/validation and risk management. Soft Skills: Strong project management, organizational, and analytical skills. Excellent communication skills for technical writing, reporting, and cross-team collaboration. Ability to lead and mentor, as well as work independently or in teams. Preferred Skills & Attributes
Experience in clinical investigations and product commercialization. Demonstrated record of technical innovation and product launches. Experience with regulatory bodies (FDA, ISO, CE), risk assessment, and quality systems. Hands-on experience with prototyping and manufacturing scale-up. Benefits
Opportunity to work on groundbreaking medical technologies that improve patient outcomes. Competitive salary, bonus eligibility, and promotionwe are growing! Professional development and cross-functional networking in a high-performing, innovative and hands-on environment. Exposure to international clinical leaders, state-of-the-art labs, and global medical device markets. This job offers a dynamic role for engineers ready to lead and innovate in the medical device Design field, making a tangible impact on patient health and safety