Sr R&D Engineer - Trainer

Position Summary:

R&D Engineer Trainer

Key Responsibilities:

• Lead the design and development of new medical devices, from feasibility studies through product launch.
• Oversee product development lifecycle including

  concept generation

  ,

  prototyping

  ,

  design verification & validation

  ,

  risk analysis

  , and

  design transfer

  to

  manufacturing

  .
• Ensure compliance with

  FDA, ISO 13485, MDR, IEC 60601, ISO 14971

  and other applicable regulations and standards.
• Drive

  innovation

  by identifying new technologies, materials, and processes that enhance product performance and cost-effectiveness.
• Lead technical design reviews, root cause analysis, and continuous improvement initiatives.
• Collaborate with cross-functional teams including Quality, Manufacturing, Regulatory Affairs, and Marketing to ensure successful product development and launch.
• Manage

  design documentation

  including

  Design History File

  (DHF),

  Design Inputs/Outputs

  , and

  Risk Management Files

  .
• Provide technical leadership and mentorship to junior engineers and project teams.
• Interface with clinicians,

  key opinion leaders

  (KOLs), and end-users to incorporate clinical feedback into design.
• Lead problem-solving initiatives for product performance, reliability, and usability.
• Stay updated with medical device industry trends, regulatory changes, and emerging technologies.

Qualifications & Requirements:

• Bachelor's or Master's degree in

  Biomedical Engineering, Mechanical Engineering, Materials Science, or related field

  .

• 10-15+ years of progressive experience in R&D within the medical device industry.

• Strong knowledge of medical device product development processes, including Design Control per 21 CFR Part 820.
• Proven track record of successfully launching medical devices into global markets.
• Expertise in

  CAD tools (SolidWorks/Creo/AutoCAD)

  , prototyping, and testing methods.
• Experience with

  risk management (ISO 14971), usability engineering (IEC 62366), and biocompatibility standards (ISO 10993)

  .
• Strong project management and leadership skills with experience in leading cross-functional teams.
• Excellent problem-solving, analytical, and communication skills.
• Experience with

  Class II

  and

  Class III medical devices

  preferred.
• 
  

Core Competencies:

• Innovation & Creativity in Medical Device Development
• Regulatory & Quality compliance mindset
• Leadership & Mentorship abilities
• Cross-functional Collaboration
• Strong Analytical and Technical problem-solving
• Strategic thinking with hands-on execution