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Principal Engineer NPI

1 month ago

Raleigh, North Carolina, United States Merz North America Full time
Job Summary

The Principal Engineer for New Products Integration will 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
  • Design, build, and test products per 21CFR820 using design for manufacturing approach to mitigate risk and improve design.
  • Lead simulations, fabrication, testing, and develop product requirements, test plans/protocols, and their execution.
  • Work with design partners on device design and synchronize with Merz project management to identify and execute necessary efforts to satisfy project objectives.
  • Identify risks and create mitigations, review and discuss tooling and/or testing needs, and develop multiple contingency plans throughout the development process.
  • Lead engineering prototype builds, including generating BOMs, ordering parts and materials, and develop incoming inspection standards and training lab technicians as necessary.
  • Provide technical expertise to cross-functional groups, including operations, quality, regulatory, and clinical teams, especially in technical explanation and root cause analysis.
  • Create and maintain accurate documentation throughout the design and development process per GDP and GMP.
  • Write test plans, procedures, work instructions, rationales, memos, and data analysis as it relates to technical requirements and specifications.
  • Develop test equipment and methods to verify and/or 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.
  • 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, 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).
  • Must be 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.

Merz North America is an equal opportunity employer/protected veterans/individuals with disabilities. The contractor will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant.