The Design Engineer I is an entry-level engineering role responsible for supporting the design, development, and improvement of medical devices, specifically focusing on spinal implants and instruments. This role involves working closely with senior engineers to assist in bringing new products to market, supporting existing product lines, and ensuring compliance with industry standards and regulations. The Design Engineer I will contribute to the product development lifecycle, from concept to production, under the guidance and supervision of more experienced engineers.

Responsibilities:

Assist in the design and development of new products and custom products by creating detailed engineering drawings, 3D models, and specifications using CAD software (e.g., SolidWorks)
Support the conceptualization and design of spinal implants and instruments, applying basic GD&T (Geometrical Dimensioning and Tolerancing) principles
Work with senior engineers to generate rapid prototypes (e.g., SLA, FDM) and proof of concepts for evaluation and testing
Contribute to minor product development projects, such as line extensions, under the supervision of senior engineers or project managers
Participate in cross-functional team activities, including design reviews, and assist in ensuring key deliverables are met
Maintain accurate and up-to-date project documentation, including engineering drawings, design history files, and other records
Collaborate with manufacturing, quality, and regulatory departments to ensure designs are manufacturable and compliant with industry standards
Assist in design verification and validation activities, including mechanical testing and the design of experiments
Participate in risk management activities, such as dFMEA (Design Failure Mode and Effects Analysis)
Assist with the development of technical documentation to support regulatory submissions (e.g., 510(k) filings)
Ensure compliance with GMP, design control procedures, and the company’s quality management system during all design activities
Identify opportunities for design improvements and cost reductions through the application of basic DFM (Design for Manufacturability) principles
Stay informed on industry trends, materials, and technologies to enhance personal knowledge and contribute to product development
Support the development of intellectual property (IP) by contributing new ideas for inclusion in the company’s IP portfolio

Qualifications:

Bachelor’s Degree in Mechanical Engineering, Biomedical Engineering, or a related field
0-2 years of experience in product design and development, preferably in the medical device industry (internship or co-op experience is a plus)
Familiarity with CAD software (e.g., SolidWorks) and basic proficiency in GD&T
Basic understanding of DFM principles and manufacturing processes such as milling, turning, and additive manufacturing
Strong mechanical design aptitude and problem-solving skills
Ability to work effectively as part of a cross-functional team
Good communication skills, both written and verbal
Familiarity with design control processes and regulatory compliance (ISO 13485, 21 CFR Part 820) is a plus
Ability to manage multiple tasks simultaneously while working under supervision
Enthusiasm for learning and growing within the field of medical device design

Zavation Medical Products, LLC

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