23 Oct
|
SolidPro - HelixA
|
Hyderabad
23 Oct
SolidPro - HelixA
Hyderabad
Title: Senior Engineer
- Material Compliance Experience
• 5 to 8 years of experience in Material Compliance, Product Stewardship, Regulatory material compliance, or related engineering roles within medical devices or other highly regulated industries.
• Hands-on experience managing compliance with global materials regulations, including but not limited to REACH, RoHS, MDR, PFAS, TSCA, Prop 65, POP, CMR, ED, and similar frameworks.
• Experience performing material compliance gap assessments, identifying missing or incomplete MoC/EPP data, and driving closure through internal teams and suppliers.
• Proven experience responding to internal, customer, and regulatory inquiries related to material compliance and environmental product data.
• Working knowledge of medical device quality and regulatory systems, including ISO 13485, MDR requirements, and integration of material compliance into design controls and lifecycle management.
• Experience collaborating cross-functionally with R&D;, QARA, Supply Chain, Procurement, and Suppliers.
• Familiarity with material compliance data systems and tools (e.g., BoM Check, Assent, iPoint, PLM/ERP compliance modules) and managing large, complex datasets.
• Experience working in a global or international business environment, supporting multiple regions and stakeholders preferred. Required Skills
• Solid technical background in R&D; engineering disciplines.
• Excellent problem-solving,
critical-thinking, and decision-making capabilities, with the ability to assess risk and recommend practical solutions.
• Strong technical reading and writing skills, with the ability to interpret regulatory text and translate it into clear, actionable requirements.
• Demonstrated ability to create high-quality technical reports, summaries, and compliance documentation for internal and external audiences.
• Ability to work under pressure, manage competing priorities, and meet tight deadlines with strong follow-through and accountability.
• Strong organizational and analytical skills, with high attention to detail and data accuracy.
• Ability to value diverse perspectives and experiences, and to establish trust and mutual respect when working with stakeholders across functions, cultures, and geographies.
• Effective communicator capable of engaging technical and non-technical audiences with clarity and confidence.
• Comfortable operating in matrixed, international teams and navigating ambiguity in evolving regulatory environments.
• Ability to work well in a team environment.
• Independent and detail oriented.
• Education
• Bachelor's degree in Materials Science, Chemistry, Chemical Engineering, Mechanical Engineering, or related scientific discipline.
• Master's degree or advanced certification in relevant disciplines are preferred.
📌 Senior Engineer (Hyderabad)
🏢 SolidPro - HelixA
📍 Hyderabad