Medical Device Materials Engineer

Medical Components, Inc.; Harleysville (PA); On-site; USD 90,000 - 120,000; Full time

Job summary

Medical Components, Inc. seeks a Materials Engineer to provide technical expertise in material selection and qualification for disposable medical devices—from concept through commercialization.

This role collaborates with cross-functional teams and ensures adherence to Design Control standards, quality systems, and regulatory requirements. The ideal candidate will have strong material characterization experience and knowledge of ISO 10993, EU MDR, and FDA guidance, with leadership within

Qualifications

• Bachelor's degree in a materials-related field and 3–5 years in medical devices.
• Experience with ISO 14971/ISO 10993, EU MDR, FDA guidance.
• Experience in material characterization and design for manufacturability.

Responsibilities

• Lead material selection and qualification for product design and development.
• Evaluate material changes and perform required validation and testing.
• Review designs for manufacturability, performance, and cost.
• Ensure release of materials, drawings, and documentation.
• Collaborate with suppliers to define processing and support production.
• Support regulatory submissions and responses for FDA/EU MDR.
• Travel to other facilities 5–15%.

Skills

Material characterization

Regulatory compliance

Leadership mentoring

Problem solving

Education

Bachelor's degree in Materials Science, Polymer Science, Chemistry or related technical field

Tools

SolidWorks

Mold flow

FEA

Job description

Medical Components, Inc. seeks a Materials Engineer to provide technical expertise in material selection and qualification for disposable medical devices—from concept through commercialization.

This role collaborates with cross-functional teams and ensures adherence to Design Control standards, quality systems, and regulatory requirements. The ideal candidate will have strong material characterization experience and knowledge of ISO 10993, EU MDR, and FDA guidance, with leadership within