HomeEngineeringSr Manager - Device Development(Mechanical) | Biocon Ltd | Bengaluru

Sr Manager – Device Development(Mechanical) | Biocon Ltd | Bengaluru

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Biocon Limited is a globally recognized, innovation-led organization that is enabling access to high quality, advanced therapies for diseases that are chronic, where medical needs are largely unmet and treatment costs are high.

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We are driven by the belief that the pharmaceutical industry has a humanitarian responsibility to provide essential drugs to patients who are in need and to do so with the power of innovation. In line with this belief, Biocon has developed and commercialized a differentiated portfolio of novel biologics, biosimilars, and complex small molecule APIs in India and several key global markets, as well as, generic formulations in the U.S. and Europe. We are a leading global player for biosimilars and APIs for statins, immunosuppressants, and other specialty molecules, with customers in over 120 countries.

We have built an employee-friendly environment for our gender-diverse workforce that is comparable to the best in the world. This has been validated once again by our position among the Top 20 Best Employers in the Biotech Industry as ranked by the prestigious Science magazine. We have been recognized for being a socially responsible organization with loyal employees who are providing global leadership in innovation.

Position: Sr Manager – Medical Device Development – Mechanical

Location: Electronic City, Bengaluru, Karnataka, India

Job Description:

Roles and 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 Candidate Profile:

  • 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

Qualification: B.Tech/M.Tech Mechanical

Experience: Min. 12 years of experience in medical device design and development.

Salary: Negotiable

Contact Details:

Ms. Pranjali Waghaye

pranjali.waghaye@biocon.com

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