Bio-Mechanical Engineer for our client in Trumbull, CTJob Title: Bio-Mechanical EngineerJob Location: Trumbull, CTJob Type: ContractJob Description:Responsibilities:
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 the problems, and recommends and implements solutions.
May lead projects of limited complexity.
May lead technicians.
Skills:
Experience with mechanical design tools (SolidWorks, AutoCAD), GD&T, Finite Element Analysis, free body diagrams, FMEA, engineering drawings, and documentation.
Statistical analysis.
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 in analysis and problem-solving.
Proficiency in the design of experiments, protocol and model development, testing, and documentation.
Familiarity with lab testing and fabrication equipment (force gauges & test stands 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.
Interactions:
Interacts with R&D staff, and cross-functional partners (Marketing, Manufacturing, RA, QA, labeling, legal, etc.) daily.
Interacts with customers and vendors.
Will interact with organizational leaders on an infrequent basis.
Reports to R&D team leader.
Accomplishments:
Has launched products in the medical device field of limited complexity.
Contributed as a team member to the launch of new products.
Contributed as a team member to sustaining engineering activities.
Qualifications:
Master's Degree in Engineering, Management, or Business with 15+ years of industry experience, 10+ in medical devices.
Bachelor's degree in Biomedical or Mechanical Engineering.
Thorough understanding of medical device manufacturing, especially as it relates to FDA (cGMP) and EU MDD manufacturing requirements.
