NPI Engineer/Medical Device in Boston, MA at Volt

Date Posted: 3/4/2021

Job Snapshot

  • Employee Type:
    Direct Hire
  • Location:
    Boston, MA
  • Duration:
    N/A
  • Date Posted:
    3/4/2021
  • Job ID:
    261077
  • Contact Name
    Volt Branch
  • Phone
    (781) 496-4360

Job Description



NPI Engineer/Medical Device

Responsibilities

  • Develop, document, SOPs, to support manufacturing process of new product and fulfill design and change controls
  • Work with the Design Team to ensure manufacturability and effective design transfer of new products to commercialization.
  • Responsible for selection, installation, qualification (IQ/PQ/OQ) of tooling and/or capital equipment utilized in product manufacture.
  • Define tooling and equipment maintenance activities and intervals.
  • Create project schedules and provide budgetary input for cost reduction and new product projects. Documents project activities.
  • Participate in the selection and qualification of new suppliers. Works closely with suppliers, purchasing and development to ensure design requirements are adequately defined and met.
  • Ensure new product manufacturability by conducting research, feasibility testing, and process validation.
  • Conduct and document verification/validation/engineering testing.
  • Conduct time studies to determine accurate labor standards for products supported.
  • Set up workflow routers and bill of materials in ORACLE/AGILE database.
  • Generate and implement Engineering Change Orders.
  • Provide progress reports to management as required.


Qualifications

  • Minimum of a bachelor’s degree in Biomedical Engineering, Mechanical Engineering or related field.
  • Entry level position or individual with 4-7 years in development of implantable medical devices.
  • Must know basic designing with ProEngineer or other design software.
  • Must have strong interpersonal and organizational skills, possess multitasking capability, be computer literate, and be able to work independently.
  • Basic understanding of GD&T

 Volt is an equal opportunity employer.