Technical Lead

Responsibilities:Lead technical planning and execution of NPI projects from concept through commercialization.Collaborate with R&D, Quality, Regulatory, Manufacturing, and Supply Chain teams to ensure smooth product transition.Own the technical documentation including design history files (DHF), product specifications, and risk assessments.Apply Design for Manufacturability (DFM), Design for Assembly (DFA), and process validation (IQ/OQ/PQ) principles.Serve as the main technical contact for suppliers, contract manufacturers, and internal stakeholders.Support regulatory submissions (e.g., 510(k), PMA) with technical data and validation reports.Drive root cause analysis and implement corrective actions during product design and pilot runs.Ensure all development activities comply with ISO 13485, FDA QSR (21 CFR Part 820), and other relevant standards.Requirements:Bachelor’s or Master’s degree in Mechanical, Biomedical, Electrical Engineering, or related field.7+ years of engineering experience in the medical device industry, with 3+ years in an NPI or technical lead role.Strong knowledge of medical device product lifecycle, especially development and manufacturing transfer phases.Proven experience with design controls, risk management (ISO 14971), and validation protocols.Familiarity with CAD software (e.g., SolidWorks), PLM systems, and ERP tools.Excellent leadership, communication, and project management skills.Preferred Qualifications:Experience with Class II or Class III medical devices.Six Sigma or Lean Manufacturing certification.