EXALTA Group · 7 hours ago
Project Engineer
Bethlehem, PA
Full-time
Onsite
Senior Level
5+ years expEXALTA Group is seeking a Project Engineer to manage and develop new products through collaboration with customers and internal teams. The role involves leading projects, ensuring compliance with quality standards, and maintaining project schedules while communicating effectively with stakeholders.
Health CareLife ScienceManufacturingMedical DevicemHealth
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
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
Qualification
Required
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
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
Company
EXALTA Group
Born from the fusion of Intech, Tyber and Resolve, EXALTA Group is a global solutions provider for the MedTech industry.
1001-5000 employees
Funding
Current Stage
Late StageTotal Funding
$0.23MKey Investors
National Science Foundation
2025-01-14Acquired
2019-03-12Grant· $0.23M
2013-11-26Seed
Leadership Team
Jeff Tyber
Chief Executive Officer and Founder
David Hannah
Chief Technology Officer
Recent News
2025-12-15
Company data provided by crunchbase