Mechanical Project Engineer II
At CooperSurgical, women's health is our focus. We are the trusted source for medical instruments, devices, and disposables that serve the healthcare needs of women throughout their lives. We continue to foster that position through expansion of our core businesses and the introduction of advanced, technology-based products that aid clinicians in the management and treatment of commonly seen conditions.
R&D is currently seeking a dynamic Mechanical Project Engineer II to join our team based in Trumbull, CT. The right candidate will be excited to provide mechanical design support to existing and in-development products, be comfortable in a fast-paced environment, and derive satisfaction from knowing that their efforts ultimately lead to improved quality of life for our patients.
The Engineer II is the technical resource on a product development or sustaining engineering team and performs their duties under the guidance of more experienced engineers. The position is responsible for ensuring that project objectives are met accurately and on time. Responsibilities include design, development, testing, troubleshooting, technical documentation, transfer to manufacturing and support of manufacturing, and conformance to all relevant regulations.
Designs, prototypes, tests, and develops components, sub-assemblies, and systems of low to moderate complexity.
Creates test protocols, runs experiments and writes test reports.
Completes product documentation of moderate complexity.
Analyzes low to moderate complexity engineering problems, defines problem, recommends and implements solutions.
May lead projects of limited complexity.
May lead technicians.
Experience with mechanical design tools (SolidWorks, AutoCAD), GD&T, Finite Element Analysis, free body diagrams, FMEA, engineering drawings and documentation.
Familiarity with designing and testing using rapid prototyping techniques.
Design, fabrication and testing experience with common manufacturing techniques for high-volume, disposable parts - machining, injection molding, stamping, casting, MIM, etc.
Experience with root cause analysis and corrective/preventive action procedures.
Experience inventing, innovating and launching products.
Proficiency with analysis and problem solving.
Proficiency with design of experiments, protocol and model development, testing and documentation.
Familiarity with lab testing and fabrication equipment (force gauges & test stands w/data acquisition, 3d printers, etc.)
Experience interacting with all functions within a business.
Experience in clinical and pre-clinical settings.
Ability to utilize common office and web-based software (email, spreadsheets, word processing, presentations) effectively.
Ability to present technical materials to non-technical personnel up to 2 levels higher effectively.
Knowledgeable of and work within FDA, MDD, ISO, CSI and other relevant standards.
Work is expected to contribute to the launch of new products, defining and solving field and manufacturing related problems as a supporting or lead member of a team.
Work contributes to projects that are critical to the future success of the business.
Interacts with R&D staff, cross-functional partners (Marketing, Manufacturing, RA, QA, labeling, legal, etc.) on a daily basis.
Interacts with customers and vendors.
Will interact with organizational leaders on an infrequent basis.
Reports to R&D team leader.
Has launched products in the medical device field of limited complexity.
Contributed as team member to launch of new products.
Contributed as team member to sustaining engineering activities.
Bachelor's Degree in Engineering with 5+ years industry experience, Master's degree in engineering management or business with 3+ years industry experience.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) and EU MDD manufacturing requirements.
CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran
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.