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Senior New Product Development Specialist

10 - 12 years

0 Lacs

bengaluru karnataka india

Posted:1 week ago| Platform: Foundit logo

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Skills Required

dfa design control risk-based development change control dfm cad tools catia design transfer documentation practices medical device design process validation eu mdr creo project planning audit readiness project management tools iso 14971 iso 13485 validation stage-gate processes gmp fda 21 cfr part 820 regulatory compliance fda qsr product design product development documentation excellence risk management

Work Mode

Remote

Job Type

Full Time

Job Description

Job Title: New Product Development Trainer

Location: Remote

Job type: Part -time

Job Summary:

NPD Trainer

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 methodologies

    concept 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.

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Senior New Product Development Specialist

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bengaluru, karnataka, india