Job Description

This is a highly technical role inside the CooperSurgical R&D New Product Development (NPD) group developing firmware and electronics systems in support of various electromechanical product launches. Within the scope of this role are electro-mechanical connected systems and devices associated with In-vitro Fertilization (IVF) and Assisted Reproductive Technologies (ART). This role will also have an opportunity to be involved in activities associated with surgical devices and instruments in a broader women’s health field including Obstetrics and Gynecology (OBGYN).

CooperSurgical’s purposeful setting of integrated Front-end Innovations and New Product Development provides an exciting opportunity for R&D engineers to be involved in end-to-end product development from a user centric front-end innovation process, via rigorous product development, to market launch.

This is a high-profile specialist role responsible for defining firmware architecture, coding, prototyping, and verifying firmware, electrical and electronics designs for complex product development initiatives. The Staff Firmware Engineer is expected to work independently under limited supervision and will be responsible for entire project workstreams within firmware and electrical engineering domain. This role will provide inputs on R&D technical directions and is expected to collaborate closely with multi-discipline cross- functional teams with significant impact on departmental results. The Engineer in this role is expected to interface and lead development partners and user community to come up with robust designs and solutions.

• 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). May have responsibility for communicating with parties external to the organization and manage external development partners to meet project deliverables on time.
• Work to influence parties within and outside of the technical function at an operational level regarding policies, practices, and procedures.

Drive improvement, refinement and consistent global implementation of firmware / software development procedures and best practices as well as other applicable Design Control guidelines.

Travel:

This role is primarily site based which requires occasional travel relating to cross-functional meetings, vendor visits, training and/or conference attendance

• 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

Work Environment:

• Handling and working with electrical and mechanical lab equipment
• Prolonged sitting in front of a computer

Experience:

• Minimum of 7 years of closely related experience in development of firmware for complex electrical systems in medical device industry.
• Minimum of Bachelor of Science Degree in Computer Science, Electrical Engineering, Electronics, Robotics, Mechatronics, Computer Engineering or combination of related fields. Advanced degrees are strongly preferred.

Education:

• Minimum of Bachelor of Science Degree in Computer Science, Electrical Engineering, Electronics, Robotics, Mechatronics, Computer Engineering or combination of related fields. Advanced degrees are strongly preferred.