Project Engineer

The Project Engineer will be a part of the R&D team working with cross functional teams with one or more projects to design and develop product(s) maintaining ISO 13485 Quality System compliance. The Project Engineer will support in modeling/designing components into detailed drawings and documentation using CAD and other tools.ResponsibilitiesESSENTIAL DUTIES AND RESPONSIBILITIES:Designs, develops, and documents implants and instruments utilizing 3D CAD modeling software and company design control processes.Model product concepts using current tools, analysis techniques, and technologies through use of parametric CAD software and other mechanisms.Perform mechanical design/redesign of medical device products applying industry standards (e.g., ASME Y14.5M-1994) to detail drawings.Support project teams responsible for new product development from concept through product launch with efficient speed to market essential.Generates technical protocols and reports for implant and instrument verification and validation testing.Oversees the maintenance of solid models and drawings (in both electronic and print form, as appropriate) for Design History Files, prototyping, and product production.Generates and maintains design control documentation for the project Design History File (DHF).Creates and processes Engineering Change Orders (ECO's).Performs the required activities and generates the appropriate documents to ensure compliance with ISO 13485 Design Control standards, FDA Good Manufacturing Processes (GMP), and to support 510(k) submissions or IDE clinical studies.Participate in the development of inspection drawings, techniques, and specifications.QualificationsBachelor's Degree in Mechanical Engineering or Biomedical Engineering.2-5 years of R&D/Product Development experience in implantable orthopedic medical device industry experience.Strong experience in Solidworks and or CREO (Pro-E).and Microsoft Office SuiteFamiliarity with rules, regulations, best practices and performance standardsOther Skills and Attributes:Good level of understanding of FEA in general.Knowledge in the use and interpretation of geometric dimensioning and tolerance (i.e., GD&T per ASME Y14.5-2009).Experience with creating project related design control documents (i.e., project schedules, Design Inputs, FMEAs, V&V reports, etc.) as required by various regulatory / certification bodies (i.e., FDA, BSI, CFDA, etc.).Knowledge with anatomy as it pertains to artificial orthopedic joints preferably hip and knee.Strong interpersonal skills. Regular interaction with customers and team members requires a friendly approachable demeanor.Ability to communicate professionally, effectively, and efficiently in person, on the telephone, over the Internet and in all correspondence. 8. Must have a strong workPHYSICAL DEMANDSN (Not Applicable) Activity is not applicable to this position.O (Occasionally) Position requires this activity up to 33% of the time (0 - 2.5+ hrs/day)F (Frequently) Position requires this activity from 33% - 66% of the time (2.5 - 5.5+ hrs/day)C (Constantly) Position requires this activity more than 66% of the time (5.5+ hrs/day)Physical DemandsStand OWalk OSit CManually Manipulate OGrasp NReach Outward NReach Above Shoulder NSpeak CClimb NCrawl NSquat or Kneel OBend OLift/Carry10 lbs or less O11-20 lbs O21-50 lbs O51-100 lbs NOver 100 lbs NPush/Pull12 lbs or less O13-25 lbs N26-40 lbs N41-100 lbs NWORK ENVIRONMENTOffice EnvironmentThe success of our organization relies on the kind of creative thinking that can only result from a diverse team of individuals. Maxx Orthopedics is proud to be an Equal Employment Opportunity employer. We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics. EOE

Created: 2025-03-03