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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 electromechanical connected systems and devices associated with Invitro 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 womens health field including Obstetrics and Gynecology (OBGYN).
CooperSurgicals purposeful setting of integrated Frontend Innovations and New Product Development provides an exciting opportunity for R&D engineers to be involved in endtoend product development from a user centric frontend innovation process via rigorous product development to market launch.
Organizational Impact:
This is a highprofile 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 multidiscipline 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.
Essential Functions & Accountabilities:
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.
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 crossfunctional 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.
Qualifications
Knowledge Skills and Abilities:
Previous technical leadership or program management experience including planning coordinating and managing R&D and/or managing development partners and/or crossfunctional 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.
Handson craft skills and experience with building circuits debugging firmware soldering fixing servicing and/or fabricating concepts fixtures and prototypes.
Proven and hands on experience in coding C/C and state machines
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 CortexM microcontrollers and their common peripherals. Experience with the implementation of realtime operating systems (FreeRTOS Zephyr others)
Experience in SPI I2C CAN buses.
Understanding of statistical methods including Design of Experiments
Work Environment:
This role is primarily site based requiring occasional travel relating to crossfunctional meetings vendor visits trainings and/or conference attendance. Prolonged sitting in front of a computer can be expected as well as working in the lab handling electrical equipment and performing testing.
Experience:
Minimum of 7 years of closely related experience in development of firmware for complex electrical systems in medical device industry.
Education:
Minimum of Bachelor of Science Degree in Computer Science Electrical Engineering Electronics Robotics Mechatronics Computer Engineering or combination of related fields. Advanced degree strongly preferred.
Required Experience:
Staff IC
Full-Time