Position : Sr. Manager Medical Device Development – Mechanical
- 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
Research Design Engineering
Pharmaceuticals Medical Devices Biotechnology