Domain: Anesthesia Workstations, Syringe Infusion Pumps. Volumetric Infusion Pumps, Patient Monitors, ECG, Defibrillators, Neonatal care, respiratory care
Qualification:
- Bachelor's / Master Degree of Mechanical Engineering with 8-10 years of design experience
- Experience in product development of Syringe Infusion Pumps. Volumetric Infusion Pumps, Patient Monitors, ECG, Defibrillators, etc
- Familiarity of ISO 13485, ISO 60601, ISO 14971, and other regulatory standards
Job Summary:
- You will be responsible to lead the NPD design team of patient critical care devices to all the Product design needs during the NPD and Product Improvement activities.
- You will own new, exciting Patient Care Devices and technology using state-of-the-art equipment while focusing on product design, on-time updates & problem solving.
- You must have expertise in development of mechanical products, team building skills, talent management, conflict resolution, and global cross-functional stake holder management.
- Lead Project plan of all stage gates, design documentation and Knowledgebase across R&D team
Responsibilities:
- Lead and do Design Project Plan for NPD projects.
- Lead and do 2D/3D Drawings/models/multiple concepts for NPD projects.
- Interact with clinicians, third-party vendors, manufacturers, sub-contractors, cross functional team members to develop and refine design requirements.
- Ensure that the manufacturing requirements translate into product design.
- Develop Risk Management Plan & execute Risk Management activities defined by the plan.
- Lead all areas of mechanical development including Jigs & Fixture designs, Mold designs.
- Develop and delivers the regulatory compliance requirement and reliability goals in product design.
- Plan and execute system integration activities to minimize issues in verification and validation.
- Develop test plans, test protocols, and test reports for product integration testing.
- Develop Document traceability from requirements to verification activities, and from requirements to design entities.
- Liaison with team members to analyze medical device communication protocols
- Review biomedical specifications of device drivers and Consolidate information directly with device manufacturers when needed.
- Understand the know-how of HL7 and software development concepts.
- Review Summarized results, contributes to the generation of technical reports, and completes experimental paperwork/lab notebook documentation.
- Assist with Illustrations and Presentations
- Follow Allied Medical reporting policies and procedures.
Experience:
- Professional Certification on GD&T (ASME or Equivalent)
- Must have knowledge of gas pressure calculation and its measurement.
- Must have knowledge of application like Pressure Valves, regulators, elastomeric seals, metals etc.
- Expertise in Robust Modelling and Detailing practices following the ASME guidelines.
- In depth experience in CAD tools such as CREO / Solid works, AutoCAD, and PLM.
- Must have strong knowledge of Engineering fundamentals and application of same during concept generation or re-design of products.
- Strong understanding of medical device standards, guidelines and regulations per ISO 13485, ISO 14971, and Design controls (21 CFR Part 820).
- Well versed in component manufacturing processes (Plastic injection molding, Extrusion, Metal injection molding, Sheet metal stamping, Machining, Powdered metal)
- Should have Knowledge on 3D printing and additive manufacturing technologies.
- Should have Knowledge on Change management, reverse engineering and technology transfer process preferred.
Soft Skills:
- Effectively collaborate with cross functional teams in a multinational matrix organization.
- Outstanding Communication ; Ability to articulate fluently and concisely
- Team building, effective communication, talent management.
Role Type:
- Full Time, In-office, based out of our office in Bhiwadi.
- Should be ready to move anywhere in India or abroad.
- Should be ready to visit to Suppliers / Vendors and Customers if needed.
