Technical Lead - Diverse Lynx : Job Details

Technical Lead Location - Arlington, TN Key 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.

Qualifications:

• 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.

Diverse Lynx LLC is an Equal Employment Opportunity employer. All qualified applicants will receive due consideration for employment without any discrimination. All applicants will be evaluated solely on the basis of their ability, competence and their proven capability to perform the functions outlined in the corresponding role. We promote and support a diverse workforce across all levels in the company.