Manufacturing Engineer

Job Description

Salary: $70k - $80k Annually plus Bonus and Benefits

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 manufacturing engineer is responsible for providing manufacturing support for existing products and for developing and introducing new products and equipment.

ESSENTIAL FUNCTIONS

Designing and developing manufacturing procedures, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.

Providing production line support including, but not limited to, implementing process improvements, troubleshooting equipment, and addressing operator inquiries.

Generating and modifying manufacturing process documentation and assuring that manufacturing processes and related documentation follow established policies and procedures. - Utilizing LEAN, Six Sigma, and other best practice tools and principles for day-to-day problem solving and continuous improvement.

Assisting in identifying equipment needs on the production floor and evaluating internal and external options for sourcing such equipment.

Generating and modify component and assembly drawings using Solid Works.

Developing and releasing new products using customer or internal specifications.

Writing and executing process and equipment validations (IQ/OQ/PQ)

Working with R&D, Marketing, Quality, and Manufacturing Departments during the concept, prototyping, and release of new products

Working with the Internal Audit team to perform annual schedule of quality system audits.

Working with external vendors as needed.

Performing equipment maintenance by following manufacturer’s instructions and established procedures.

Other assignments as requested.

DESIRED KNOWLEDGE, SKILLS AND ABILITIES

Bachelor’s Degree/Technical Degree in Mechanical Engineering.

Minimum of 3 years’ experience in a medical device manufacturing environment.

LEAN manufacturing experience.

Experience/knowledge with process and equipment validation, PFMEA, IQ/OQ/PQ, etc.

CAD experience/knowledge.

Candidate must possess good project management skills and initiative in taking on and completing projects.

Candidate must possess good verbal and written communication skills.

Catheter manufacturing experience (preferred).