medical device lead with NPI/NPD experinace only W2 Position Available In Shelby, Tennessee
Tallo's Job Summary: The role of Technical Lead in Arlington, TN requires a Bachelor's or Master's degree in Engineering, with 7+ years of experience in the medical device industry. Responsibilities include leading NPI projects, collaborating with cross-functional teams, and ensuring compliance with ISO 13485 and FDA regulations. Strong communication and project management skills are essential, along with experience in design controls and risk management.
Job Description
medical device lead with NPI/NPD experinace only W2
Role:
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.
Preferred Qualifications:
Experience with Class II or Class III medical devices.
Six Sigma or Lean Manufacturing certification.
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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Dice Id:
91159647
Position Id:
8639250
