Materials Engineer

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. #J-18808-Ljbffr Medical Components, Inc.