What are the responsibilities and job description for the Manufacturing Engineer - Medical Devices (34678) position at Myticas Consulting?
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
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.
- 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.
- 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 60601-1 and related medical electrical safety standards.
- 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.
- 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 60601-1.
- 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.
- 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 62366-1, ISO 14971, or other medical device standards.
- Experience with PCB rework, firmware loading, or embedded systems is a plus.