Material science engineer - biocompatibility iso 10993

Material Science Engineer

Location: Preference will be given to candidates located within a reasonable commuting distance of Harleysville, PA for on-site work. Remote candidates may be considered for exceptional qualifications and must reside in AZ, FL, GA, NJ, NC, TN, or TX. Please note: This position is not eligible for relocation assistance or employment sponsorship now or in the future.

Position 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, material science, medical device manufacturing, ISO 10993, EU MDR, FDA Guidance regulatory compliance 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.
• 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.
• Collaborate with Biocompatibility, Manufacturing, Research & Development (R&D), and New Product Development (NPD) teams to support material science, chemical characterization, and product safety activities for FDA, EU MDR, and global regulatory submissions, technical documentation, and regulatory responses.
• Evaluate material composition, additives, impurities, processing aids, degradation products, and residual chemicals.
• Assess material, supplier, formulation, manufacturing, sterilization, and packaging changes, determine requires testing, validation, risk assessment, and regulatory documentation for proposed changes.
• Prepare responses to FDA, notified body, and other regulatory deficiencies related to materials and biocompatibility.
• Interpret and review complex chemical data sets from outside analytical and biological laboratories and compare results to supplier documentation.
• Evaluate scientific evidence and develop defensible conclusions using a weight-of-evidence approach.
• Maintain material and material property databases.
• Support manufacturing operations and resolve production issues.
• Travel to other facilities as needed (5–15%).

Required Qualifications

Education & Experience

• Bachelor's degree in Materials Science, Polymer Science, Chemistry or related technical field.
• 3–5 years of experience in manufacturing or medical device industry.
• Strong experience in material characterization and selection in accordance with ISO 14971, ISO 10993 Series of Standards, EU MDR, and FDA Guidance.
• Experience in engineering design, validation, and product testing environments.

Technical Skills

• Knowledge of ISO 10993, ISO 14971 is required.
• 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).

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.