At NAGL MedTech™, we offer a wide array of roles to support medical device companies of any size at any stage. Our model utilizes a fractional but best-in-class workforce approach to Medical Device Development. The result is optimal talent deployed when the project requires it, which improves time to market without the risk of heavy fixed costs. NAGL MedTech™ associates are trained to our FDA and ISO compliant Quality System and Business Systems, or our teams can flex into the client’s systems if that is more advantageous.

GENERAL

The Principal Design Engineer is responsible for researching and developing ideas and processes for new products, improving upon the performance and design of existing products and overseeing production and packaging of a final product. The Principal Design Engineer coordinates and exercises functional authority for planning, organization, control, integration and completion of the project. The Principal Design Engineer may also be assigned to special projects that are commensurate with his or her level of experience.

ESSENTIAL FUNCTIONS

• Designs, models, and tests prototypes for products and provide production support to the machining area and the assembly area.
• Produces and designs engineering sketches, specifications and related data and drawings to determine design factors.
• Conducts research and creates design proposals for projects.
• Plans and formulates the engineering program and organizes project staff according to project requirements.
• Assigns project personnel to specific phases or aspects of projects such as technical studies, product design, preparation of specifications and technical plans, and product testing.
• Reviews product design for compliance with engineering principles, company standards and customer contract requirements, and related specifications.
• Coordinates activities concerned with technical developments, scheduling and resolving engineering design and test problems.
• Directs the integration of technical activities and products.
• Evaluates and approves design changes, specifications and drawing releases.
• Controls expenditures within the limitations of project budget.
• Prepares interim and completion project reports.
• Measures machines and parts during production to ensure compliance with design specifications.
• Uses computer assisted design/drafting equipment and software to develop designs.

DESIRED KNOWLEDGE, SKILLS AND ABILITIES

• A bachelor’s degree in Engineering or a relevant scientific discipline, with a minimum of 7 years of experience and 3-6 years of experience in a medical device or pharmaceutical environment, OR an equivalent combination of education and experience.
• Knowledge of manufacturing processes and/or experience in medical device operations.
• A thorough understanding of the QSR and ISO regulatory environments.
• Exceptional organizational and time management skills, verbal and written communication skills, and the ability to understand advanced mathematical concepts.
• Logical thinking and problem-solving skills as well as high level of creativity.
• Knowledge in the use of CAD and basic computer software.
• Auditing skills.
• Proficiency in Windows and Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
• Proficiency in Statistical Software.
• And the ability to work independently.
• Ability to present design concepts and prototype functionality to doctors, business people, or other VIPs at a level commensurate with the audience’s technical understanding.