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Job Summary

The Development Engineer is responsible for designing and developing medical device product(s) including concept development, requirements generation, prototype fabrication, assembly and component design, as well as generation of engineering documentation. This role is also responsible for testing finished products for quality purposes and recommending changes to product specifications, as necessary. S/he will use a wide degree of creativity and latitude to accomplish varied and complicated tasks relying on experience and judgement to plan and accomplish goals and may act as the lead designer with minimal supervision.

Essential Job Functions

• Performs the design, development, implementation, and analysis of systems, products, assemblies, and components that meet specified requirements.
• Acts as a project lead in the definition, planning, and requirements generation of new or updated products.
• Delivers on-time, on-quality, and on-budget project tasks.
• Performs engineering qualification, verification, and validation testing for new and updated components and assemblies.
• Complies with all SOP and regulatory requirements pertaining to the development of medical devices (per FDA 21 CFR part 820 and ISO 13485).
• Utilizes CAD to create and modify 3D components and assemblies and their associated drawings per industry standards.
• Develops and maintains product and/or process documentation (such as specification documents, Bill of Materials, Design History Files, Engineering Change Orders, etc.).
• Assists with outside manufacturer selection, evaluation, and communication and provides support in the establishment and maintenance of suppliers.
• Demonstrates a strong ability to work within a team as well as manage his or her responsibilities as an individual contributor.
• Promotes and adheres to the company values of quality and compliance with current legislation.

Qualifications

• Requires a bachelor’s degree in engineering and minimum 3 years’ experience in the field or in a related area.
• Technical knowledge and understanding of the medical device industry.
• Computer literate with experience in Microsoft Office applications.
• Intermediate level 3D and 2D computer aided design software experience required. Solidworks and/or SolidEdge experience preferred.

Competencies

Demonstrates ownership and accountability; the ability to plan, execute, control, and deliver; communicate effectively both written and verbal; perform repetitive tasks; multitask and prioritize; apply knowledge and understanding of the medical industry; lead and influence others effectively and without authority.

Physical Requirements

Performing the duties of this job regularly involves sitting or standing; hearing/listening; repetitive hand movement; grasping; reaching. Performing the duties of this job may require the occasional lifting and carrying of up to 100 lbs. as well as bending and/or stooping. Vision requirements include the ability for close vision, the ability to adjust focus, and to color code.

Mental Requirements

This position requires the ability to maintain an appropriate work pace; comprehend and follow instructions; exercise logic and reasoning; organize and prioritize; read; compose written communication; communicate verbally; problem solve and make decisions; analyze and interpret data; multi-task/re-direct and experience numerous interruptions. This position requires the ability to maintain the highest standards of professional maturity and emotional intelligence even in difficult or stressful situations.

Other Requirements

Minimal business travel required, less than 10% of the time (domestic and international).

Work Environment

The noise level in the work environment is usually quiet to moderate. Occasionally this position will be in a lab or machine shop environment where the noise level will be loud.