Job Title: Sr. Project Engineer
Department: R&D / Product Development
Reports to: R&D Manager or above

Description: Manage and develop new products through regular interaction with customers and internal cross-functional teams. The Sr. Project Engineer is expected to lead a project and report on status with senior internal and external personnel when needed. The Sr. Project Engineer may have direct reports and could be responsible for taking on multiple projects.

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 (e.g., 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.
• Manage cost, resourcing, and performance of projects within your team.
• Work with the leadership team to develop a strong vision of the future. Planning and developing the right talent to align with this will be a priority.

Secondary Job Responsibilities:

• Support business development and management activities.
• 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.
• 8+ years of product development experience in the 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.
• Strong QMS knowledge (e.g., leading CAPAs, reviewing PMCF documents, implementing CIs).
• Proven capability in managing relationships with customers and suppliers.
• Expert in Microsoft Office and video conferencing (Teams), especially PowerPoint.
• Effective communication, organization, and the ability to solve problems and overcome obstacles.
• Successful track record of bringing new products to market.
• Ability to influence all levels within the organization and put together a cross-functional team.