Senior NPI Engineering Specialist

2 weeks ago

Raleigh, North Carolina, United States Merz Aesthetics Full time


The Lead Engineer for New Product Integration (NPI) will oversee projects throughout the product development lifecycle, collaborating with the R&D team during feasibility assessments and prototype creation, progressing through verification and validation stages, and facilitating the transition of designs into production.

This role entails managing both in-house development initiatives and external design partnerships.

Accountable for delivering cross-functional technical expertise to quality assurance, operations, regulatory compliance, marketing, and clinical teams, the engineer will employ sound judgment and engineering practices while demonstrating effective leadership capabilities.


Key Responsibilities:
Product Development:
Design, construct, and evaluate products in accordance with 21CFR820, utilizing a design-for-manufacturing approach to minimize risks and enhance product design.

The responsibilities encompass leading simulations, fabrication, testing, and developing product requirements, as well as test plans and protocols, ensuring their execution.


Project Management:

Collaborate with design partners on device architecture and synchronize efforts with project management to meet project goals.

Identify potential risks and formulate mitigation strategies, review tooling and testing requirements, and develop multiple contingency plans throughout the development cycle.


Prototype Manufacturing:

Direct engineering prototype production, including generating Bills of Materials (BOMs), ordering components and materials, establishing incoming inspection standards, and training laboratory technicians as needed.

Work closely with product development, NPI, suppliers, and R&D to pilot the manufacturing and assembly processes for new device constructions.


Subject Matter Expertise:

Provide technical guidance to cross-functional teams, including operations, quality assurance, regulatory, and clinical groups, particularly in technical explanations and root cause analyses.


Documentation:
Develop and maintain precise documentation throughout the design and development phases in compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Testing Methods:

Participate in the creation of test plans, procedures, work instructions, rationales, memos, and data analyses related to technical specifications and requirements. Engage in the development of testing equipment and methodologies to verify and validate tools or setups as necessary.


Qualifications:
Professional Experience: Minimum of 7 years in relevant development roles within the medical device or electronics sectors
At least 5 years of experience in R&D product development, successfully launching devices or enhancing product features
A minimum of 3 years mentoring and supervising engineers and technicians

Required Knowledge, Skills, and Abilities:
Proficient in design for manufacturing from feasibility to production transfer
Familiarity with electrical or electronic characterization techniques, including ultrasound devices
Strong understanding of the product development process and proven ability to lead verification and validation efforts for design transitions
Capability to develop Requests for Proposals (RFP), Requests for Quotations (RFQ), and Statements of Work (SOW) for internal teams or external vendors
Proficient in SolidWorks, Finite Element Analysis (FEA), and statistical or Design of Experiments (DOE) techniques
Experience in designing and developing new products or features requiring coordination among multiple functional teams
Recognized as a subject matter expert in at least one engineering discipline (e.g., Electrical Engineering, Software, Ultrasound, Mechanical Engineering, etc.)
Strong interpersonal skills for effective communication with cross-functional teams
Knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
Proficient in Microsoft Word, Excel, and PowerPoint
Familiarity with acoustic standards (IEC, 21CFR1050.10, MIL-STD-1376), ISO13485, and 21 CFR 820:30.

Education:
Required: Bachelor's Degree in Mechanical Engineering, Electrical Engineering, or a related engineering discipline

Preferred:
MBA or Master's Degree in Mechanical Engineering, Electrical Engineering, or a related engineering discipline

Equal Opportunity Employer/Protected Veterans/Individuals with Disabilities

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