Technical Lead
Technical Lead
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
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:
- Bachelors or Masters 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.
Additional Information :
All your information will be kept confidential according to EEO guidelines.
Remote Work :
No
Employment Type :
Contract
Employment Type
Contract
