Biocon

Position : Sr. Manager Medical Device Development – Mechanical

Key Responsibilities:

  • To Build & Lead the design, development and testing of mechanical sub-systems for electro-mechanical device and accessories for drug delivery systems
  • Identify, evaluate and drive development projects with suppliers and partners.
  • Develop new design solutions & drive innovation. Ideation, design and hands-on prototyping and feasibility testing of design concepts.
  • Form and lead a team of mechanical engineers with direct reports to design and develop new and innovative products
  • Has direct responsibility of part lifecycle management for mechanical parts & sub-systems. Create & maintain design documentation (BOM’s, Specifications, Drawings)
  • Has direct responsibility to set-up engineering labs & infrastructure to facilitate ideation, prototyping and testing of design concepts
  • Reviews and approves Critical Features and design risk assessments (dFMEA)
  • Supports internal and external regulatory audits
  • Facilitates cross functional team problem solving & continuous design improvement projects

Desired Skills & Experience:

  • A minimum of 12 years of experience in medical device design and development.
  • BE / Mtech in Mechanical Engineering
  • 5+ years of technical leadership on mechanical design projects
  • 5+ years of experience in identifying key skill sets, leading teams & manpower management.
  • Hands-on skills with the proven ability to independently apply deep technical knowledge to lead complex mechanical designs.
  • Required to have experience in complete product lifecycle i.e. from product conceptualization to design development and manufacturing of medical devices
  • Strong design skills including working knowledge of CAD design tools & analytical tools (Solidworks, Creo).
  • Electro-mechanical integration and electronics exposure
  • Solid understanding of general manufacturing processes like injection molding & machining with experience in tool engineering and design.
  • Experience in Vendor management, component/material selection with experience in part / sub-assembly design development, prototyping and verification
  • Should have worked with global R&D teams & suppliers.
  • Strong Knowledge & understanding of medical device regulations like ISO13485, EU MDD & US FDA 21 CFR 820 & standards requirements like IEC60601, ISO14971, IEC62304 etc..
  • Possess a high level of integrity with a passion to work with entrepreneurial teams in a rapidly growing organization
  • Strong Hiring & talent management skills
  • Excellent written and verbal communication
  • Strong presentation skills
  • Seniority level

    Mid-Senior level

  • Employment type

    Full-time

  • Job function

    Research Design Engineering

  • Industries

    Pharmaceuticals Medical Devices Biotechnology

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