Technical Lead, Engineering, Quality Engineering
Job in
Arlington, Shelby County, Tennessee, 38002, USA
Listed on 2026-06-02
Listing for:
Fisec Global
Full Time
position Listed on 2026-06-02
Job specializations:
-
Engineering
Quality Engineering, Manufacturing Engineer, Biomedical Engineer, Medical Device Industry
Job Description & How to Apply Below
- 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.
- 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., Solid Works), PLM systems, and ERP tools.
- Excellent leadership, communication, and project management skills.
- Experience with Class II or Class III medical devices.
- Six Sigma or Lean Manufacturing certification.
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