Engineer II/Laboratory Lead

• Track record and deep understanding of rapid prototyping technologies, machining (CNC, lathe, Bridgeport), and other fabrication techniques (welding, laser cutting, thermoforming...) used to create high fidelity prototypes with high level of tight tolerance craftmanship.

• Working knowledge of SolidWorks modeling and creating / editing complex surfaces.

• Ability to design and fabricate test fixtures intended for verification testing

• Electronics pick and place soldering and hand soldering proficiency to produce prototype PCB assemblies

• Test & lab equipment and instrument proficiency (3 D printers, Instron, Oscilloscope, Keyence & other microscopes, power tools…..)

• Experience with machine controls (robot arm testing deployment...) for testing

• Statistical knowledge needed to run TMV / MSA studies and draw conclusions in reports. Understanding of statistical methods including Design of Experiments (DOE) is preferred

• Ability to write detailed test protocols and verification reports

• Medical device development knowledge with understanding of Design Control guidelines as defined by FDA, MDR, ISO, CSI, and other standards. Ability to translate User Needs to Design Inputs to create Verification Test protocols, and perform verification testing, and publish Verification Test reports.

• Proficient in MS Office Suite (Excel, Word, PowerPoint)

• Handle daily administrative duties of the laboratory: keeping stock of consumables, tools, etc.

• Knowledge of, and commitment to, safety requirements for machines and facilities

• Manage calibrations of laboratory assets

• Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from project engineers and consultants to key opinion leaders and executives .
  

• Handling and working with electrical and mechanical lab equipment

• Occasionally lift to 35 Kilograms

• Prolonged sitting in front of a computer
  

• Minimum of 2 years of closely related experience in development of complex electro-mechanical systems in medical device industry.
  

• Minimum of Bachelor of Science Degree in Electrical Engineering, Mechanical Engineering, Robotics, Mechatronics, or combination of related fields. Advanced degree strongly preferred.
  

As an employee of CooperSurgical, you'll receive an outstanding total compensation plan. As we believe your compensation goes beyond your paycheck, we offer a great compensation package, medical coverage, 401(k), parental leave, fertility benefits, paid time off for vacation, personal, sick and holidays, and multiple other perks and benefits. Please visit us at www.coopersurgical.com to learn more about CooperSurgical and the benefits of becoming a member of our team.

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.

• End to end prototyping with high craftmanship standards covering development activities from User Needs realistic mockups to high resolution prototypes for verification testing.

• Coordinate testing activities and prioritization in lab multiple sites

• Plan and enhance lab equipment capability

• Manage test equipment safety, calibration, debug, and repair

• Create formal Verification test protocols, run tests, and write Verification test reports.

• Test Method Validation (TMV) execution and report writing

• Manage lab inventory and consumables

• Collaborate with engineers and conduct design reviews to drive proper design for prototyping practices

• 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 electro-mechanical systems. Drive, coach and/or oversee definition of design input (i.e., product requirements) and technical strategies for an adequate verification and validation approach.
  

• Track record and deep understanding of rapid prototyping technologies, machining (CNC, lathe, Bridgeport), and other fabrication techniques (welding, laser cutting, thermoforming...) used to create high fidelity prototypes with high level of tight tolerance craftmanship.

• Working knowledge of SolidWorks modeling and creating / editing complex surfaces.

• Ability to design and fabricate test fixtures intended for verification testing

• Electronics pick and place soldering and hand soldering proficiency to produce prototype PCB assemblies

• Test & lab equipment and instrument proficiency (3 D printers, Instron, Oscilloscope, Keyence & other microscopes, power tools…..)

• Experience with machine controls (robot arm testing deployment...) for testing

• Statistical knowledge needed to run TMV / MSA studies and draw conclusions in reports. Understanding of statistical methods including Design of Experiments (DOE) is preferred

• Ability to write detailed test protocols and verification reports

• Medical device development knowledge with understanding of Design Control guidelines as defined by FDA, MDR, ISO, CSI, and other standards. Ability to translate User Needs to Design Inputs to create Verification Test protocols, and perform verification testing, and publish Verification Test reports.

• Proficient in MS Office Suite (Excel, Word, PowerPoint)

• Handle daily administrative duties of the laboratory: keeping stock of consumables, tools, etc.

• Knowledge of, and commitment to, safety requirements for machines and facilities

• Manage calibrations of laboratory assets

• Excellent interpersonal and effective communication skills with internal and external stakeholders ranging from project engineers and consultants to key opinion leaders and executives .
  

• Handling and working with electrical and mechanical lab equipment

• Occasionally lift to 35 Kilograms

• Prolonged sitting in front of a computer
  

• Minimum of 2 years of closely related experience in development of complex electro-mechanical systems in medical device industry.
  

• Minimum of Bachelor of Science Degree in Electrical Engineering, Mechanical Engineering, Robotics, Mechatronics, or combination of related fields. Advanced degree strongly preferred.