Senior Manufacturing Engineer (Electronics)
Senior Manufacturing Engineer (Electronics)
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Bluedrop Medical is an innovative medical device company focused on advanced wound care solutions. Our mission is to reduce complications from chronic wounds through cutting-edge sensor technology and remote monitoring. As we transition from product development to commercial-scale manufacturing, we are building a high-performance operations team to support this next stage of growth.
Position Summary
We are seeking a hands-on, proactive Senior Manufacturing Engineer (Electronics) to lead and support the industrialisation, validation, and continuous improvement of electronic subassemblies and system-level manufacturing processes. You will be a key interface between R&D, Quality, and our Contract Manufacturer, ensuring smooth transfer of knowledge and scalable production solutions.
This is a critical role for the commercialisation phase of our device and demands a detail-oriented engineer with strong electronic manufacturing experience and a passion for quality and reliability.
Key Responsibilities
Process Development & Optimization
* Develop, document, and improve PCBA and system-level assembly processes in collaboration with the Contract Manufacturer
* Lead DFM (Design for Manufacturability) and DFA (Design for Assembly) reviews with R&D and CM.
* Specify and support deployment of tooling, fixtures, and test equipment.
Technical Support & Issue Resolution
* Act as the primary point of contact for electronic manufacturing issues at the Contract Manufacturer.
* Troubleshoot yield, quality, and process stability issues.
* Manage root cause analysis and implement corrective actions.
Validation & Compliance
* Lead and execute process validations (IQ/OQ/PQ) for manufacturing and test processes.
* Ensure all processes and documentation comply with ISO 13485 and FDA regulations.
* Drive process improvements for quality, throughput, and cost reduction.
* Monitor key manufacturing metrics (FPY, yield, downtime)
* Maintain and improve manufacturing SOPs, WI, and PFMEAs.
* Work cross-functionally with R&D, QA/RA, Supply Chain, and the Contract Manufacturer to support seamless production.
* Support the ECO process and manage BOM and drawing updates impacting production.
Qualifications
* Bachelor's degree in Electronic Engineering, Manufacturing Engineering, or related field.
* 3–7 years of experience in electronic manufacturing, preferably within the medical device industry.
* Strong knowledge of SMT, PCBA inspection/test, and electronics assembly methods.
* Experience with process validation, quality systems, and documentation standards for medical devices.
* Familiarity with Lean Manufacturing, Six Sigma, or similar methodologies.
* Excellent analytical, communication, and cross-functional collaboration skills.
* Proficiency in ERP/MRP systems and Microsoft Office Suite. Familiarity with Altium or similar ECAD tools is a plus.
Preferred Attributes
* Experience working with contract manufacturers and managing remote manufacturing support.
* Exposure to regulated environments (ISO 13485, FDA 21 CFR Part 820).
* Ability to thrive in a fast-paced, startup-like environment.
* Proactive mindset with strong ownership and accountability.
Why Join Us?
* You’ll be joining Bluedrop Medical at a pivotal moment—scaling a product that has the potential to significantly improve patient outcomes in chronic wound care. You’ll be part of a small, agile, and passionate team, where your work will have a real impact from day one.
Seniority level
* Seniority level
Mid-Senior level
Employment type
* Employment type
Full-time
Job function
* Job function
Engineering and Information Technology
* Industries
Medical Equipment Manufacturing
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