The Principal Engineer for New Products Integration (NPI) will lead projects through the product development process from working with the rest of the R&D team through feasibility and prototype building stages, through verification and validation and conduct transfer of design into production. The engineer will be responsible for development efforts in house as well as managing external design partners. Responsible for providing cross functional technical expertise to quality, operations, regulatory, marketing, and clinical groups utilizing sound judgement and engineering practices, while displaying intelligent, and smart leadership skills.
Responsibilities

• Product development: Designs, builds, and tests products per 21CFR820 using design for manufacturing approach to mitigate risk and improve design. The scope includes leading simulations, fabrication, testing, as well as developing / creating product requirements, test plans/protocols and their execution.
• Project management: Work with design partners on device design and synchronizing 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 including, develop multiple contingency plans throughout the development process.
• Prototype manufacturing: Lead engineering prototype builds, including generating BOMs, ordering parts and materials, develop incoming inspection standards and training lab technicians as necessary. Work closely with product development, NPI, suppliers, and R&D to pilot manufacture product development and assembly efforts for new a device builds.
• Subject matter expert: Provide technical expertise to cross functional groups including operations, quality, regulatory, and clinical teams especially in technical explanation and root cause analysis.
• Documentation: Create and maintain accurate documentation throughout the design and development process per GDP and GMP.
• Test Methods: Involved is writing test plans, procedures, work instructions, rationales, memos, and data analysis as it relates to technical requirements and specifications. Involved in developing test equipment and methods to verify and/or validate tools or setup as required.

Job Related Qualifications & Skills

• Required Professional Experience:
• 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
• Required Knowledge, Skills, and Abilities:
• 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 which 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 60601-2-62, IEC 60601-2-37, 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