What are the responsibilities and job description for the New Product Development Engineer position at Invent Staffing?
Role: New Product Development (NPD) Engineer
Location: New jersey
Duration:12 Months
Experience: 3 Years
Industry: Medical Device
Job Summary:
The New Product Development (NPD) Engineer will drive the design, development, and launch of innovative medical devices.
This role requires expertise in product lifecycle management, design controls, risk management, and regulatory compliance.
The engineer will collaborate cross-functionally to ensure product safety, efficacy, and manufacturability while meeting FDA and ISO 13485 standards.
Key Responsibilities:
Lead the design and development of new medical devices from concept to commercialization.
Ensure compliance with FDA 21 CFR Part 820, ISO 13485, IEC 60601, and other applicable regulations.
Develop and execute design verification & validation (DV&V) protocols, including testing and documentation.
Conduct design risk assessments (DFMEA, PFMEA) and implement risk mitigation strategies.
Collaborate with R&D, Quality, Regulatory, and Manufacturing teams to ensure a smooth transition from development to production.
Develop and optimize product specifications, drawings, and tolerance analysis.
Utilize CAD software (SolidWorks, Creo) for design, prototyping, and modeling.
Support material selection, process development, and supplier qualification for components and assemblies.
Implement design for manufacturability (DFM) and design for assembly (DFA) principles.
Conduct root cause analysis, CAPA, and troubleshooting during product development.
Lead or support regulatory submissions (510(k), PMA, CE Mark) by providing technical documentation.
Apply Lean, Six Sigma, or other process improvement methodologies to enhance product performance.
Qualifications:
Bachelor’s or Master’s degree in Mechanical, Biomedical, or related engineering field.
3 years of experience in new product development (NPD) within the medical device industry.
Strong knowledge of design controls, risk management, and validation protocols.
Experience with GMP, FDA, ISO 13485, and IEC 60601 compliance.
Proficiency in CAD software (SolidWorks, Creo) and statistical analysis tools (Minitab, JMP).
Hands-on experience with prototype development, rapid prototyping, and testing.
Strong problem-solving, project management, and cross-functional collaboration skills.
Excellent communication and documentation abilities to support regulatory and quality compliance.
