Senior New Product Development Specialist

Job Title: New Product Development Trainer

Location: Remote

Job type: Part -time

Job Summary:

We are seeking an experienced NPD Trainer with over a decade of hands-on expertise in medical device design, product development, validation, and regulatory compliance. The Trainer will be responsible for designing and delivering structured training programs to upskill engineers, technicians, and project managers in end-to-end new product development processesfrom concept to commercialization. The ideal candidate should possess strong technical depth, familiarity with ISO 13485, FDA 21 CFR Part 820, and Design Control requirements, and the ability to translate complex product development concepts into effective, practical learning experiences.

Key Responsibilities:

Training & Curriculum Development

• Design, develop, and deliver technical training modules on:
• Medical device design and development lifecycle
• Design input, output, verification, and validation
• Risk management (ISO 14971)
• Design transfer and process validation
• Change control and documentation practices
• Develop training content using case studies, product samples, and simulation exercises.
• Assess training needs and tailor programs for R&D, Quality, and Manufacturing teams.

Technical Expertise & Mentoring

• Provide hands-on guidance in product design, prototyping, DFM/DFA, and CAD tools.
• Train on regulatory requirements for design history file (DHF), device master record (DMR), and technical documentation.
• Mentor cross-functional teams on project planning, stage-gate processes, and risk-based development.

Quality & Compliance Training

• Educate teams on ISO 13485, FDA QSR, EU MDR, and GMP requirements in NPD.
• Support internal capability building for audit readiness and documentation excellence.

Continuous Improvement

• Evaluate training effectiveness through post-training assessments and performance KPIs.
• Collaborate with HR and R&D leaders to identify skill gaps and update the curriculum accordingly.

Required Skills & Competencies:

• In-depth understanding of Medical Device Design Controls and Regulatory Frameworks (FDA, ISO, CE).
• Strong knowledge of product development methodologiesconcept design, prototyping, testing, validation, and transfer to manufacturing.
• Proficiency in CAD software (SolidWorks/Creo/Catia) and project management tools.
• Excellent communication, presentation, and coaching skills.
• Ability to simplify complex technical topics for multi-level audiences.
• Exposure to cross-functional collaboration among R&D, QA/RA, and Manufacturing teams.

Educational Qualification:

• B.E./B.Tech/M.E./M.Tech in Mechanical, Biomedical, or related Engineering discipline.
• Certification in Design Control, Project Management (PMP/Lean Six Sigma) or Quality Systems is an added advantage.