Sr. Project Engineer

Modern Machining Solutions Inc; Bethlehem (Northampton County); Sur place; USD 105 000 - 145 000; Plein temps

Résumé du poste

Modern Machining Solutions Inc. seeks an experienced Sr. Project Engineer to lead new product development through active collaboration with customers and internal teams.

You will drive schedules, milestones and risk management while owning engineering activities such as drawings, protocols, and DHF documentation. The role requires 8+ years in medical device product development, CAD/Drafting expertise (SolidWorks preferred), GD&T, FEA, and strong communication skills to influence multiple

Qualifications

• Bachelor's degree in mechanical or biomedical engineering or related field.
• 8+ years of product development experience in the medical device industry desirable.
• Expert CAD skills (SolidWorks preferred) with GD&T, FEA and DFM knowledge.

Responsabilités

• Lead and manage product development projects with customers and cross-functional teams.
• Communicate status, milestones, risks and issues to senior management and customers.
• Maintain project schedules, coordinate across departments, resolve problems, and drive actions.
• Own engineering activities on projects: drawings, protocols, test reports, DHF documentation.
• Support forecasting, quoting, purchasing, regulatory expansion, and post-market activities as needed.
• Coordinate and lead cadaver labs.
• Promote continual improvement across interacting departments.
• Manage cost, resources, and performance of projects within the team.
• Collaborate with leadership to develop a future vision and align talent.

Connaissances

CAD/Drafting

GD&T

FEA

Technical writing

Project leadership

Cross-functional collaboration

Communication

Problem solving

Formation

Bachelor's degree in mechanical or biomedical engineering

Outils

SolidWorks

ISO 13485

CFR 820

Description du poste

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.