Description: Manage and develop new products through regular interaction with customers and internal cross-functional teams. The Project Engineer is expected to lead a project and report on status with senior internal and external personnel when needed.

Primary Responsibilities:

Ensure all product development activities are conducted in accordance with design controls and the company's quality management system, as well as additional customer specifications.
Communicate effectively and present project information and status when requested to ensure customers, project team, and senior management are aware of upcoming milestones and risks/issues.
Maintain project schedule by monitoring progress, coordinating activities with other departments, resolving problems, and recommending actions.
Manage engineering ownership of activities on assigned projects. This may include conducting activities as well (ex: author/review drawings, protocols, test reports, DHF documentation, etc.).
Before and after active development, assist other departments with activities like forecasting, quoting, purchasing, regulatory expansion, and/or post-market activities.
Coordinate and lead cadaver labs.
Promote and ensure continual improvement in all interacting departments.

Secondary Job Responsibilities:

Inspect inventory components and supervise first product builds.
Participate in trade shows and other possible conferences.
Respond to field questions related to products and projects when necessary.

Educational/Experience Requirements:

Bachelor’s degree in mechanical or biomedical engineering, or relevant engineering discipline or work experience.
5+ years of product development experience in medical device industry is desired.

Knowledge/Skills Desired:

Expert in CAD/Drafting (SolidWorks preferred), GD&T, FEA, DFM, and technical writing.
Experience with DHFs, ISO 13485, CFR 820, and CE technical files.
Proven capability in managing relationships with customers and suppliers.
Proficient in Microsoft Office and video conferencing (Teams), especially PowerPoint.
Effective communication and ability to assist in problem solving and overcoming obstacles.

Note: duties or functions listed may not necessarily comprise all the essential functions. Exalta Group reserves the right to revise the job or require that other tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel, workload, rush jobs, or technical developments).

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