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Chief Engineer for Product Integration

2 months ago

Raleigh, North Carolina, United States Merz Aesthetics Full time


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

This role entails managing in-house development activities as well as coordinating with external design partners.

Accountable for delivering cross-functional technical insights to quality assurance, operations, regulatory compliance, marketing, and clinical teams, while demonstrating sound judgment and effective leadership capabilities.


Key Responsibilities:
Product Development:
Responsible for designing, constructing, and evaluating products in accordance with 21CFR820, employing a design for manufacturing approach to minimize risks and enhance design quality.

This includes leading simulations, fabricating prototypes, testing, and formulating product requirements, as well as developing and executing test plans and protocols.


Project Management:

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

Identify potential risks and devise mitigation strategies, review tooling and testing requirements, and establish multiple contingency plans throughout the development phases.


Prototype Manufacturing:

Oversee engineering prototype production, including generating Bills of Materials (BOMs), procuring components and materials, and developing incoming inspection standards while 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:
Ensure the creation and maintenance of precise documentation throughout the design and development phases in compliance with Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP).

Test Methods:

Participate in drafting test plans, procedures, work instructions, rationales, memos, and data analyses related to technical specifications and requirements.

Involved in developing testing equipment and methodologies to verify and validate tools or setups as necessary.
Qualifications & Skills Required:
- 7+ years of relevant development experience in the medical device or electronics sector
- 5+ years of experience in R&D product development, successfully launching devices or product features
- 3+ years of experience mentoring and supervising engineers and technicians

Essential Knowledge, Skills, and Abilities:
- Proficient in design for manufacturing, from feasibility through production transition
- Familiarity with electrical or electronic characterization, including ultrasound devices
- Strong understanding of the product development process and proven capability in leading verification and validation efforts
- Ability to develop Requests for Proposals (RFP), Requests for Quotations (RFQ), and Statements of Work (SOW) for internal teams or external vendors
- Common use of SolidWorks, Finite Element Analysis (FEA), and statistical or Design of Experiments (DOE) techniques
- Expertise in designing and developing new products and features requiring coordination across multiple functional areas
- Recognized subject matter expert in at least one engineering discipline (e.g., Electrical Engineering, Software, Ultrasound, Mechanical Engineering)
- Strong interpersonal skills facilitating 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 and regulations.

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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