Principal Engineer NPI

4 days ago

Raleigh, North Carolina, United States Merz North America Full time
Job Title: Principal Engineer NPI

Merz North America is seeking a highly skilled Principal Engineer NPI to lead projects through the product development process from feasibility and prototype building stages to verification and validation and conduct transfer of design into production.

Key Responsibilities:
  • Product Development: Design, build, and test products per 21CFR820 using design for manufacturing approach to mitigate risk and improve design.
  • Project Management: Work with design partners on device design and synchronize with Merz project management to identify and execute necessary efforts to satisfy project objectives.
  • Prototype Manufacturing: Lead engineering prototype builds, including generating BOMs, ordering parts and materials, and developing incoming inspection standards.
  • Subject Matter Expert: Provide technical expertise to cross-functional groups, including operations, quality, regulatory, and clinical teams.
  • Documentation: Create and maintain accurate documentation throughout the design and development process per GDP and GMP.
  • Test Methods: Develop and implement test plans, procedures, and work instructions to verify and validate tools or setup as required.
Requirements:
  • 7+ years of related development experience in the medical device and/or electronics industry.
  • 5+ years' experience within R&D product development creating devices and/or adding product features that were successfully released.
  • 3+ years' experience mentoring and supervising other engineers and technicians.
Preferred Qualifications:
  • Knowledge of design for manufacturing, from feasibility through transfer to production.
  • Familiarity with electrical or electronic characterization, such as impedance, acoustic tank, pulse-echo, force balance, transmitting voltage response, and ultrasound devices.
  • Strong familiarity with the product development process and proven capability leading verification and validation efforts for design transfer.
  • Ability to develop RFP, RFQ, and SOW for internal functional groups or outside vendors.
  • Common use of SolidWorks, Finite Element Analysis (FEA), Statistics or DOE techniques.
  • Design and development of new products, features that require orchestration of deliverables from multiple functional groups.
  • Considered subject matter expert in at least one engineering discipline (e.g., EE, SW, Ultrasound, Mechanical, etc.).
  • Effective interpersonal skills enabling constructive communication with cross-functional groups.
  • Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
  • Proficient in MS Word, Excel, and PowerPoint.
  • Familiarity with acoustic standards (IEC, IEC, 21CFR1050.10, MIL-STD-1376), ISO13485, 21 CFR 820:30.
Education:
  • Required: Bachelor's Degree in ME or EE or other relevant Engineering discipline.
  • Preferred: MBA / Master's in ME or EE or other relevant Engineering discipline.

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