Senior Medical Device Project Lead

Modern Machining Solutions Inc; Bethlehem (Northampton County); On-site; USD 105,000 - 145,000; Full time

Job summary

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.

Responsibilities

• 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.

Skills

CAD/Drafting

GD&T

FEA

Technical writing

Project leadership

Cross-functional collaboration

Communication

Problem solving

Education

Bachelor's degree in mechanical or biomedical engineering

Tools

SolidWorks

ISO 13485

CFR 820

Job description

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