Senior Director, Embedded Systems & Process Engineering (ESPE)
US: Indianapolis IN Tech Center North, United States
USD 156K-228K Senior-level Full Time
Tasks
- Define PLC based control architectures
- Define assembly and joining technology standards
- Drive design for assembly and design for manufacturability
- Ensure ISO 13485 and ISO 14971 compliance
- Ensure electrical safety sensor actuator and signal integration
- Ensure medical device design controls and regulatory compliance
- Establish safety circuits interlocks and fail safe design
- Govern automation and control architectures
- Govern external partner and supplier embedded development
- Lead embedded systems strategy
- Manage assembly process FMEAs and risk assessments
- Oversee CQV documentation
- Oversee HMI and operator interaction
- Oversee IEC 60601 and IEC 62304 compliance
- Oversee joining technology selection and qualification
- Partner with manufacturing quality digital and IT for validation and data integrity
- Provide embedded electronics firmware and system integration oversight
- Resolve assembly yield throughput and automation downtime issues
Perks/Benefits
- N/A
Skills/Tech-stack
Actuator integration | Adhesive Bonding | Assembly automation | Automation control | CQV | Cybersecurity | Data Integrity | Design Controls | Design for Assembly | Design for manufacturability | Electrical safety | Embedded Systems | Embedded electronics | Firmware Development | Grounding | Human-Machine Interface | Industrial Automation | Joining Technology | Laser Welding | Machine Interface | Mechanical Joining | Modeling | Noise analysis | PLC | Power Distribution | Process FMEA | Risk Management | Safety interlocks | Sensor Integration | Signal Integrity | Snap Fit | System Integration | Traceability | Ultrasonic welding
Education
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