Essential Functions & Accountabilities
Formulate and deliver electrical / electronic architecture and hands on development of electrical circuit schematics for complex electromechanical systems and analyze / simulate design to understand key parameters and sensitivities. Establish design feasibility by testing circuits and demonstrating statistical capability for critical functions.
Design and de-bug electrical systems which comply to 60601 EMC and Safety requirements.
Test and characterize complex PCB functional blocks in support of firmware development. Run firmware to enable de-bugging code and circuit. Implement firmware changes in test environment to confirm solutions.
Drive medical device Design Control compliance by ensuring that all applicable safety, quality and regulatory guidelines and policies are followed to develop safe and effective electrical systems. Drive, coach and/or oversee definition of design input (i.e., product requirements) and technical strategies for an adequate verification and validation approach.
Create formal Verification test protocols, run tests, and write Verification test reports.
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.
Coach team members and collaborators in design control processes and best practices. Lead and mentor interns and junior engineers.
Manage and mentor interns
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 managing external development partners to meet project deliverables on time.
Drive improvement, refinement and consistent global implementation of electrical engineering best practices.
Knowledge, Skills and Abilities
Track record and extensive R&D experience relating to electronics in medical device development and fabrication of complex electro-mechanical systems, mechatronic, robotic and/or IT/connected systems.
Track record and deep understanding of development approaches and strategies for effective execution and delivery of complex medical device programs.
Experience with electronics, PCB, and related manufacturing techniques common to medical devices.
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.
Requires deep knowledge of technical electrical and electronics area typically obtained through advanced technical education combined with experience. Ability to perform first principles circuit calculations and circuit simulations (e.g. SPICE simulation) to confirm concept feasibility.
Expertise in analog and digital circuit design and layout using tools like Altium Schematic Capture.
Strong background in hardware/software integration and hardware debugging using appropriate tools and lab instruments.
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 verification testing, and publish Verification Test report.
Hands-on craft skills and experience with building circuits, soldering, fixing, servicing and/or fabricating concepts, fixtures, and prototypes.
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
Programming and software development experience a plus
Experience in project management and related tools.
Proficiency with analysis and problem solving
Work Environment
This role is site based requiring occasional travel relating to cross-functional 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 4 years of closely related experience in development of complex electrical systems (preferably in the medical device industry).
Education
Minimum of Bachelor of Science Degree in Electrical Engineering, Electronics, Robotics, Mechatronics, Computer Engineering or combination of related fields. Advanced degrees strongly preferred.
To all agencies: Please, no phone calls or emails to any employee of CooperSurgical about this opening. All resumes submitted by search firms/employment agencies to any employee at CooperSurgical via-email, the internet or in any form and/or method will be deemed the sole property of CooperSurgical, unless such search firms/employment agencies were engaged by CooperSurgical for this position and a valid agreement with CooperSurgical is in place. In the event a candidate who was submitted outside of the CooperSurgical agency engagement process is hired, no fee or payment of any kind will be paid.
We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender, gender identity or expression, or veteran status. We are proud to be an equal opportunity workplace. If you are interested in applying and require special assistance or accommodations due to a disability, please contact us at talent.acquisition@coopersurgical.com.
As an employee of CooperSurgical you'll receive a competitive total compensation plan. Your recruitment team will be able to share more information about any variable pay opportunity and benefit package that accompanies this role. The good faith estimate of the salary range for this role is $101,476 to $135,301. The actual amount offered is determined by a number of factors including but not limited to location, skills and experience.
