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Job Title: Senior Product Development/ Design Engineer

 Job Description:

The Senior Product Development / Design Engineer is responsible for engineering and designing medical products and surgical instruments and providing engineering leadership within the department.

Responsibilities include:

  • Create, experiment with, and evaluate new product concepts
  • Lead and Participate in project brainstorming meetings
  • Fulfilling Lead Engineer role on projects such as coordinating multi-functional activities (i.e., labs and presentations to clients), providing technical leadership to other members of the team, and acting as the primary customer contact.
  • Perform engineering activities, including, ensuring customer requirements are met, prototyping, maintaining compliance with quality system requirements, and participating in project status meetings
  • Interface with clients regarding project status
  • Perform detailed and systematic trouble shooting of designs; use DOE and Statistical Methods to support decisions
  • Assure project proceeds in accordance with the Synectic Design Control System (phases I thru VI).
  • Perform according to detailed project timeline (start up to project completion).
  • Participate in clinical and engineering test method development and validation
  • Perform quality system activities to document design in DHF and DMR; Conduct and document Design reviews, FMEA, Verification, Validation and Manufacturing / Quality planning activities
  • Participate in material, component and device assessment and selection for devices and implants
  • Participate in process design and optimization, production scale-up and technology transfer, as applicable
  • Participate in project summary reports, as applicableC. Organization RelationshipsThe Senior Product Development / Design Engineer will report directly to the Engineering Manager of the company. The Senior Product Development / Design Engineer works closely with internal and external technical teams such as other engineers, industrial designers, clinicians and vendors.
  • Job Requirements:A. Education and Experience
  • A minimum of a four year college degree in engineering or science, or equivalent experience, is required or equivalent experience. Strong listening, verbal and written communication skills required both with technical and non-technical people
  • Minimum of five or more years of demonstrated success in product design and development engineering roles with increasing responsibility in an ISO 13485 and/or FDA compliant or similarly design controlled medical device product development environment, specifically including the following experience and qualifications or equivalent experience:
    • Success in advancement of multiple new product development projects, from project startup through commercialization
    • Aptitude for creative, “out of the box” thinking, and translating customer needs into product ideas
    • Strong mechanical and problem solving abilities
    • Ability to function independently and effectively within a multi-disciplinary team
    • Strong interpersonal communication skills and presentation skills
    • Demonstrates strong client centered attitude and maximum flexibility in a rapidly changing environment
    • Works to meet project and budget requirements; plans appropriately and informs management to correct deviations
    • B. Technical Requirements
  • Extensive knowledge of medical product development and manufacturing within the mechanical medical device and surgical instrumentation industry
  • Skilled at thinking strategically, innovating and applying technical knowledge to complex problems
  • Proficient with recent versions of 3D CAD applications (SolidWorks or ProEngineer preferred),
  • Working knowledge of in-house machine shop capabilities and safety procedures.
  • Knowledge of rapid prototyping techniques, molding and extrusion methods, metal processes and components and common medical device assembly processes
  • Familiarity with tissue lab, cadaver lab, and animal lab operations and procedures
  • Familiarity with operation of typical mechanical laboratory equipment, as necessary for material, component and device performance evaluation
  • Solid data analysis, data management, basic statistics and experimental design skills
  • Proficient in problem solving methods, DOE and statistical analysis
  • Knowledge of experimental design and test / gauge R & R
  • Experience with design, fabrication and validation of simulated use and standardized product performance tests
  • Knowledge of polymer / elastomers and metal properties, and common fabrication methods and limitations
  • Knowledge of various fabrication and manufacturing methods for materials and their limitations
  • Familiarity with observing live human surgical procedures
  • Very proficient with PC-based office tools, such as Microsoft Word, Excel, Outlook, PowerPoint and Project
  • Basic knowledge of classic stress analysis, Finite Element Analysis and mold flow analysis
  • Capable of conducting patent and competitive product research on the internet.

Please submit resumes to: