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 Senior Mechanical Project Engineer 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 Senior Engineer is the primary technical resource on a product development or sustaining engineering team and performs their duties with minimal supervision. The position is responsible for providing technical leadership to the development team that includes design, development, testing, troubleshooting, technical documentation, transfer to manufacturing and conformance to all relevant regulations.
Designs, prototypes, tests and develops components, sub-assemblies, systems and full products of up to moderate complexity.
Creates test protocols, runs experiments and writes test reports.
Completes product documentation of moderate to high complexity.
Analyzes moderate to high complexity engineering problems, defines problem, recommends and implements solutions.
May lead projects of limited complexity.
May lead technicians.
Proficient with mechanical design tools (SolidWorks, AutoCAD), GD&T, Finite Element Analysis, free body diagrams, FMEA, engineering drawings and documentation.
Experience with designing and testing using rapid prototyping techniques.
Design, fabrication and testing proficiency 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.
Proficiency inventing, innovating and launching products.
Proficiency with analysis and problem solving.
Proficiency with design of experiments, protocol and model development, testing and documentation.
Experience with lab testing and fabrication equipment (force gauges & test stands w/data acquisition, 3d printers, etc.)
Proficiency interacting with all functions within a business.
Proficiency 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 numerous products in the medical device field of low to moderate complexity.
Contributed as team member to launch of new products.
Contributed as team member to sustaining engineering activities.
Bachelor's Degree in Engineering with 10+ years industry experience, Master's degree in engineering management or business with 8+ years industry experience, PhD with 3+ years industry experience.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) manufacturing requirements.
CooperSurgical is an equal employment opportunity employer and strong advocate of workforce diversity. Minority/Female/Sexual Orientation/Gender Identity/Disability/Veteran