Design Engineer - Medical Device

Are you a visionary Design Engineer passionate about improving patients' lives through innovative medical devices? Fladger Associates, an executive search and staffing leader, wants to connect you with a thrilling opportunity to advance your career. As a Design Engineer in the medical device industry, you'll have a critical role in shaping the future of healthcare technology. Explore an environment that values creativity, precision, and collaboration.

Position Summary

As a Design Engineer for medical devices, you will be at the forefront of developing cutting-edge medical devices that address complex healthcare challenges. Your expertise in design engineering will drive the creation and refinement of devices, ensuring they meet the highest functionality, safety, and compliance standards. You will work closely with cross-functional teams, including R&D, quality assurance, and regulatory affairs, to bring revolutionary medical devices from concept to market.

Key Responsibilities

In this pivotal role, your primary responsibilities will include:

• Product Design and Development: Utilize your skills in CAD software and engineering principles to design medical devices that meet rigorous industry standards.

• Prototyping and Testing: Develop prototypes for new products and conduct tests to ensure they meet design specifications and regulatory requirements.

• Cross-Functional Collaboration: Work with R&D, quality assurance, regulatory affairs, and manufacturing teams to ensure seamless product development.

• Documentation: Prepare detailed design documentation, including technical drawings, reports, and user manuals, to support regulatory submissions and product launches.

• Regulatory Compliance: Ensure all design and development activities comply with relevant medical device regulations and standards, such as FDA, ISO 13485, and CE marking.

• Continuous Improvement: Engage in continuous improvement processes to refine design methodologies and enhance product performance and reliability.

Qualifications

To excel in this design engineer job, you should possess the following qualifications:

• Educational Background: Bachelor’s or master’s degree in mechanical engineering, biomedical engineering, or a related field.

• Experience: Minimum of 3-5 years of experience in design engineering within the medical device industry.

• Technical Proficiency: Expertise in CAD software (e.g., SolidWorks, AutoCAD) and familiarity with FEA and simulation tools.

• Regulatory Knowledge: In-depth understanding of medical device regulations, standards, and certification processes.

• Problem-Solving Skills: Strong analytical and problem-solving abilities to tackle complex design challenges.

• Team Player: Excellent interpersonal and communication skills to collaborate effectively with cross-functional teams.

• Attention to Detail: Meticulous approach to design and documentation to ensure precision and regulatory compliance.