we are seeking an Engineering Manager to lead the transition of its medical devices from R&D into scalable, compliant, and cost-effective production. This role owns the Design Transfer process, drives validation and qualification efforts, maintains the engineering and manufacturing BOMs, and provides hands-on support to production. The Engineering Manager will collaborate closely with Operations, Quality, and R&D to ensure manufacturability, robustness, and readiness for global scale.
The ideal candidate has deep hands-on engineering experience in medical devices, strong knowledge of manufacturing processes, and thrives in fast-paced, cross-functional environments.
The ideal candidate has deep hands-on engineering experience in medical devices, strong knowledge of manufacturing processes, and thrives in fast-paced, cross-functional environments.
Requirements:
Bachelors degree in Mechanical, Electrical, Biomedical Engineering, or related discipline.
5+ years of engineering experience in the medical device or regulated industry.
Hands-on experience with design transfer, NPI, or production engineering.
Strong familiarity with electro-mechanical manufacturing processes (PCBA, assembly, testing).
Experience with IQ/OQ/PQ and test method validation.
Strong BOM management and document control experience (ERP/PLM).
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
Excellent problem-solving and data-driven decision-making skills.
Strong communication skills and ability to collaborate with R&D, Operations, Quality, and suppliers.
Familiarity with IEC 60601 or relevant electrical device standards (if applicable)
Nice-to-Have:
Experience working with contract manufacturers and global suppliers.
Experience in designing and validating jigs, fixtures, and test equipment.
Experience in cost-reduction initiatives and value engineering.
Previous leadership or mentoring experience of engineers/technicians.
Bachelors degree in Mechanical, Electrical, Biomedical Engineering, or related discipline.
5+ years of engineering experience in the medical device or regulated industry.
Hands-on experience with design transfer, NPI, or production engineering.
Strong familiarity with electro-mechanical manufacturing processes (PCBA, assembly, testing).
Experience with IQ/OQ/PQ and test method validation.
Strong BOM management and document control experience (ERP/PLM).
Knowledge of ISO 13485, 21 CFR 820, and ISO 14971.
Excellent problem-solving and data-driven decision-making skills.
Strong communication skills and ability to collaborate with R&D, Operations, Quality, and suppliers.
Familiarity with IEC 60601 or relevant electrical device standards (if applicable)
Nice-to-Have:
Experience working with contract manufacturers and global suppliers.
Experience in designing and validating jigs, fixtures, and test equipment.
Experience in cost-reduction initiatives and value engineering.
Previous leadership or mentoring experience of engineers/technicians.
This position is open to all candidates.
