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Senior Engineer I, Product Development Engineer

Arsenal Medical is an early-stage, medical device company that is bringing biomaterials systems to the clinic to improve patient outcomes. We are a multi-disciplinary team of biologists, chemists, materials scientists, and engineers, working in close collaboration to understand the biology of disease and to create solutions that address some of today’s most challenging and critical unmet medical needs. Arsenal Medical has created a state-of-the art research and development environment in the Boston metropolitan area.

We are looking for an experienced product development engineer to support the design and development of novel products.

Key areas of responsibility

  • Apply sound engineering principles and practices to the design, assembly, and testing of implantable, biomaterials-based medical devices and delivery systems
  • Collaborate to define, document and drive the design of prototype devices for evaluation and testing of new design attributes and product concepts
  • Develop new test methods, complete measure system analysis, support the creation of design specifications
  • Identify and establish working relationships with outside materials suppliers, OEM equipment designers, and contract manufacturers to develop designs, tooling, fixtures, test methods, and inspection methods
  • Define and execute milestones and timelines as part of project planning
  • Participate in and document development activities through lab notebook, design history file, reports and other records in accordance with Design Control (examples include Risk Analysis, Product Specifications, Verifications, Validations) and company procedures
  • Collaborate with Quality to ensure compliance to appropriate ISO/FDA regulations for the development and manufacture products, include support of applicable regulatory submission and Design History File documents
  • Develop and implement design elements including assembly, packaging and sterilization
  • Contribute to and participate in design reviews and project reviews

Qualifications

  • B.S. or M.S. in Mechanical or Biomedical Engineering
  • 5-8 years of experience in product development for disposable or implantable medical devices focusing on product design and development through commercialization, including a minimum of 3 successful product launches
  • Experience in conducting risk analysis, design verifications, and design validations
  • Knowledge and experience in product design, material processes, and assembly processes, including injection molding, machining, packaging and sterilization of single-use devices for minimally-invasive procedures
  • Working knowledge of the US and international standards governing the design, development and manufacture of medical devices
  • Experience developing products or commercial manufacturing under ISO or GMP procedures and associated quality system
  • Experience writing documents for submission to the FDA to support clinical testing or marketing approval (e.g. IDE, HDE, 510k, PMA)
  • Demonstrated skills in problem solving and applied engineering, including use of statistical tools (e.g., Minitab)
  • Applied knowledge of Design Excellence/Design for Six Sigma principles, Design of Experiments (DOE) with associated tools and methods, and Design for Manufacturing
  • Familiarity with Human Factors and usability studies and their impact on product development and design
  • Team player who enjoys working in a highly dynamic and cross-disciplinary environment
  • Excellent written and verbal communication skills

Arsenal Medical offers a casual and friendly work environment, shared medical and dental insurance, FSA, HRA, 100% paid STD, LTD, AD&D and Life, 401(k), and more!

Interested candidates should send an email to

recruiting_wss@arsenalmedical.com

Please put "Senior Engineer I, Product Development Engineer position" in the subject line to ensure your resume is properly routed

Arsenal Medical, Inc. is an Equal Opportunity Employer.