Manufacturing Engineer

Job Title: Manufacturing Engineer - Medical Devices
Contract:
W2– Candidates must be authorised to work in the U.S. on a W2 basis. We cannot accept candidates requiring sponsorship or those from C2C vendors.

Duration:
Direct Hire or Contract-to-hire

Type:
On-Site

Pay:
Depends on experience

Location:
Lake Mary, Florida

Key Responsibilities
Electromechanical Assembly & Testing

• Assemble medical equipment, subassemblies, and wiring per engineering drawings, schematics, and SOPs.
• Perform electrical wiring, soldering, connector termination, PCB installation, and cable routing.
• Conduct functional testing, calibration, and verification using test equipment such as oscilloscopes, multimeters, power supplies, and analyzers.
• Measure, document, and characterize electrical operation of circuits and systems.
• Assist in building and maintaining test fixtures, programming jigs, and production aids.

Production Support & Manufacturing Engineering

• Support production readiness and new product introduction (NPI) activities for electrical and mechanical assemblies.
• Work alongside engineering to identify and implement corrective actions that improve machine efficiency, assembly processes, and product reliability.
• Participate in equipment maintenance, troubleshooting, quality reviews, and continuous improvement initiatives.
• Assist in training production staff on assembly practices, quality requirements, and test procedures.
• Interface with materials management to support build planning, material availability, and workflow optimization.

Quality, Compliance & Documentation

• Follow all FDA QSR/GMP and ISO 13485 regulations in daily operations.
• Create, review, or maintain documentation including build instructions, test procedures, risk assessments, and device history records (DHRs).
• Support the completion of design control documentation such as DHF, traceability matrices, verification/validation protocols, and usability files when required.
• Participate in internal and external quality audits, including FDA, CE, UL, and notified body reviews.
• Ensure all assembly and testing meets IEC and related medical electrical safety standards.

Engineering Collaboration & Technical Leadership

• Work with electrical, mechanical, and systems engineers to refine designs, resolve product issues, and improve manufacturability.
• Provide feedback on electrical hardware design, component selection, and test strategy.
• Assist with failure analysis, product improvements, and engineering change implementations.
• Collaborate with PCB designers, external vendors, and component suppliers for cables, flex circuits, and assemblies.
• Support regulatory and marketing teams with technical insight for product documentation and training.

Required Qualifications

• Associate's or Bachelor's degree in Biomedical Technology, Biomedical Engineering, Electronics, Electrical Engineering Technology, Mechatronics, or related field.
• 5+ years of hands-on experience assembling and testing electromechanical or medical devices.
• Strong mechanical assembly skills including fasteners, pneumatics, tubing, alignment, and precision measurement.
• Strong electrical skills including soldering, wiring diagrams, circuit troubleshooting, and test equipment usage.
• Knowledge of medical device regulations: ISO 13485, FDA QSR/GMP, IEC
• Familiarity with CE, UL, EMC testing, or safety compliance is highly desirable.
• Ability to read electrical schematics, mechanical drawings, and technical documentation.
• Strong communication skills with the ability to work in cross-functional teams.
• High attention to detail, strong documentation habits, and a commitment to product quality.

Preferred Skills

• Experience in NPI, production engineering, or process development.
• Experience writing test procedures, work instructions, or assembly documentation.
• Hands-on debug and rework experience from prototyping through production.
• Familiarity with IEC 62304, IEC , ISO 14971, or other medical device standards.
• Experience with PCB rework, firmware loading, or embedded systems is a plus.

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