Staff Firmware Engineer

Responsibilities

• Formulate and deliver firmware architecture while influencing hardware design
• Lead firmware development for complex electromechanical systems
• Analyze and simulate design to understand key parameters and sensitivities
• Establish design feasibility by testing firmware / hardware and demonstrating statistical capability for critical functions
• Drive medical device Software Design Control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective firmware
• Drive, coach and/or oversee definition of design inputs (i.e., product requirements) and technical strategies for an adequate verification and validation approach
• Design and de-bug firmware and electronics systems which complies to IEC 62304 and other relevant medical device requirements
• Create formal Firmware Verification test protocols, run tests, and write Verification test reports
• Coach team members and collaborators in design control processes and best practices
• Lead and mentor interns and junior engineers
• Mentor and provide technical leadership for junior firmware engineers and interns
• Aid and drive an effective cross-functional collaboration ensuring timely and efficient delivery of target business outcomes
• Accountable to timely project plan deliverables in cross functional teams utilizing CooperSurgical New Product Introduction (NPI) process
• Communicate key technical content to parties within and outside of own function (R&D)

Qualifications

• Track record and extensive R&D experience relating to firmware in medical device development and integration of complex electro-mechanical systems, mechatronic, robotic and/or IT/connected systems
• An outcome focused mindset including process discipline and drive for timely project completion
• Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from project engineers and consultants to key opinion leaders and executives
• Track record and deep understanding of development approaches and strategies for effective execution and delivery of complex medical device programs
• Previous technical leadership or program management experience including planning, coordinating, and managing R&D and/or managing development partners and/or cross-functional technical programs
• Medical device development experience with thorough understanding of Design Control guidelines as defined by FDA, MDR, ISO, CSI, and other standards
• Ability to translate User Needs to Design Inputs to creating Verification Test protocols, and perform firmware verification testing, and publish Verification Test reports
• Hands-on craft skills and experience with building circuits, de-bugging firmware, soldering, fixing, servicing and/or fabricating concepts, fixtures, and prototypes
• Proven and hands on experience in coding C/C++ and state machines
• Proven and hands on experience with peripherals such as USB, SPI, I2C, UART, GPIO etc
• Solid understanding of analog circuits, signal conditioning, filters, and digital circuit design
• Proven and hands on experience in control algorithms like PID, floating point filters, etc
• Solid understanding and experience with bare metal systems (no OS) and/or embedded OS (e.g. Embedded Linux, FreeRTOS, etc)
• Working experience in circuit and layout tools like Altium Schematic Capture
• Strong background in hardware/software integration and hardware debugging using appropriate tools and lab instruments
• Working knowledge of ARM Cortex-M microcontrollers and their common peripherals
• Experience with the implementation of real-time operating systems (FreeRTOS, Zephyr, others)
• Experience in SPI, I2C, CAN buses
• Understanding of statistical methods including Design of Experiments