Senior Materials Engineer – R&D Core Materials Engineering (Polymer)
Role expectations
- Lead material selections, evaluation, and qualification across a range of polymer‑based material systems used in Align products.
- Own material strategy and execution for new product introduction (NPI), regional launches, and sustaining activities.
- Independently manage multiple parallel material workstreams with high visibility and business impact.
- Lead dental materials assessments (e.g., composites, adhesives, polymers) to support product global launch and meet regional requirements.
- Define testing strategies and deliver clear data-driven technical recommendations to cross‑functional stakeholders.
- Support medical device packaging materials and systems as part of overall material ownership.
- Design, evaluate, and optimize medical and consumer packaging for performance, manufacturability, and sustainability in accordance with ISO 11607 and ASTM/ISTA standards.
- Design and perform standard and customized polymer characterization (thermal, mechanical, rheological, spectroscopic) and long-term reliability evaluations.
- Define and approve material specifications; author validation protocols and reports documentation per Design Control and QMS requirements.
- Lead collaboration with internal teams and external partners to evaluate, qualify, and scale sustainable materials and packaging solutions globally.
- Support chemical-compliance and biocompatibility evaluations to ensure regulatory readiness and provide data for product filings.
- Translate complex test results into clear technical reports, risk assessments, and strategic recommendations that guide product and business decisions.
- Mentor and coach engineers and technicians to strengthen experimental design, data integrity, and sustainability best practices across the materials function.
- M.S., or Ph.D. degree in Polymer Science, Chemistry, Chemical Engineering, or related discipline.
- 8+ years of R&D experience involving polymers, packaging, or medical devices.
- Proven expertise in polymer characterization, structure–property analysis, and material compatibility evaluation.
- Demonstrated ability to translate material performance into product-level requirements and outcomes.
- Lead and execute hands-on laboratory testing and material characterization, including experimental design, data analysis, and interpretation.
- Practical experience in packaging materials design, development, and validation for medical or consumer products.
- Excellent technical communication and cross-functional collaboration skills.
- Proven analytical thinking and ability to translate data into practical engineering recommendations.
- Demonstrated ability to manage multiple projects and influence cross-functional stakeholders.
- Demonstrated learning agility, ownership, and a proactive, results-driven mindset.
- Ability to take initiative, follow through, and approach challenges with curiosity and persistence in a fast-paced environment.
- Strong execution, integrity, and accountability.
- Experience evaluating material interactions for chemical and functional compatibility with medical devices and packaging systems.
- Knowledge of environmental, chemical, and packaging compliance standards, including REACH, RoHS, Prop 65, TSCA, ISO 10993, and ISO 11607.
- Familiarity with sustainable packaging materials, validation methods, and relevant ASTM and ISTA test standards (e.g., ASTM F88, F1980; ISTA 3A).
- Working knowledge of design control, risk management, and validation processes in accordance with ISO 13485 and FDA QSR requirements.