Materials Engineer

This position is based in Harleysville, PA.
Local candidates only - must be within reasonable commute distance as on-site work is required on a weekly basis.
This position does not offer relocation assistance or sponsorship.

Job Summary

We are seeking a Materials Engineer to provide technical expertise in material selection and qualification for the design and development of disposable medical devices—from concept through commercialization. This role collaborates closely with cross-functional engineering teams and ensures adherence to Design Control standards, quality systems, and regulatory requirements.

The ideal candidate will bring strong experience in material characterization, medical device manufacturing, and leadership/mentorship within engineering teams.

Key Responsibilities

• Lead material selection and qualification processes for product design and development
• Evaluate material changes and define/execute required validation and testing
• Review product designs for material manufacturability, performance, and cost efficiency
• Develop and maintain specifications, bills of materials (BOMs), routers, SOPs, and SUPs
• Ensure proper review and release of materials, drawings, and documentation
• Assess material properties and compatibility for intended product use
• Collaborate with suppliers to define material processing and support production needs
• Partner with R&D, Manufacturing, Quality, Regulatory, and Biocompatibility teams
• Support design reviews, FMEAs, and verification/validation activities
• Conduct root cause analysis on product failures and drive corrective actions
• Write and execute product testing protocols; coordinate external testing per ASTM/ISO standards
• Review and summarize external lab reports
• Support regulatory submissions and global material compliance requirements
• Assist with feasibility studies and ROI analysis for capital projects
• Maintain material and material property databases
• Mentor team members and provide leadership across engineering functions
• Support manufacturing operations and resolve production issues
• Travel to other facilities as needed (5–15%)

Required Qualifications

Education & Experience

• Bachelor’s degree in Engineering, Materials Science, or related technical field
• 3–5 years of experience in manufacturing or medical device industry
• Strong experience in material characterization and selection
• Experience in engineering design, validation, and product testing environments

Technical Skills

• Knowledge of ISO standards (ISO 10993 preferred)
• Familiarity with FDA, GMP, GLP, and EU MDR regulations
• Experience with CAD software (SolidWorks preferred)
• Knowledge of injection molding, extrusion, and secondary operations
• Understanding of GD&T and engineering drawings
• Experience with validation testing methods and statistical analysis
• Familiarity with FEA and mold flow analysis

Additional Skills

• Strong problem-solving and analytical abilities
• Excellent written and verbal communication skills
• Ability to lead projects and mentor team members
• Proficiency in Microsoft Office (Word, Excel, PowerPoint, Project, Outlook)
• Lean Manufacturing certification (Green Belt preferred)

Core Competencies

• Problem solving and analytical thinking
• Technical expertise and continuous learning mindset
• Collaboration and teamwork
• Communication (written and verbal)
• Quality focus and attention to detail
• Leadership and mentoring
• Adaptability and initiative
• Sound judgment and decision-making

Physical Requirements

• Ability to sit, stand, walk, and use hands regularly
• Occasional lifting up to 25 lbs
• Ability to work in manufacturing, lab, and prototype environments
• Vision abilities including close and distance vision, color vision, and depth perception

Work Environment

• Combination of office, manufacturing floor, engineering lab, and prototype shop environments
• Exposure to mechanical equipment and moderate noise levels

Additional Information

• Travel required: 5–15%
• Must have or be able to obtain a valid passport

Equal Opportunity Statement

We are committed to creating a diverse and inclusive workplace. We provide equal employment opportunities to all employees and applicants regardless of race, color, religion, gender, age, disability, or veteran status.