Engineer

Carries out independently and according to own judgement, targeted development assignments, the broad outlines of which have already been indicated. Develops parts of a new product according to technical specifications on basis of familiar technologies. Develops materials and techniques. Prepares design releases.

Job Description :

In this role, you will have the opportunity to participate in an exciting and progressive environment developing products that save lives. You will be part of the remediation, relaunch (MLD) and NPI (New Product Introduction) Mechanical Engineering Team within the R&D (Research and Development) Department at Philips SRC (Sleep and Respiratory Care) division. You will be directly involved in the design and development of Ventilators (hospital and home) and disposables (masks).

You are responsible for

• Lead Sustenance activities for respiratory products
• Support ongoing MDD and MDR regulatory compliance
• Lead and execution remediation tasks
• Execute any verification activities as required in the lab
• Support DHF (design history file) remediation for mechanical engineering deliverables which includes; defining strategy and planning, gap analysis, creating new and revising DHFs, reviewing and releasing DHFs
• DHF s accountability and responsibility for mechanical and mechatronic parts and sub systems (Gas path, valves, sensors (air, O2 and Pressure), manifold, patient interface, solenoid valves, filters, blowers, motors and enclosure)
• Review, mentor correctness and approve design documentation including requirements specification, design docs, engineering analysis & simulation studies, calculations, capture, test plans, test procedures, test records & reports
• Lead project team members to produce development plans and identify and mitigate development risks.
• Conceive, design, develop, evaluate, and implement new systems and products in the field of medical ventilator product development and sustaining engineering.
• Utilize best practices in mechanical design analysis, modeling, and tolerance analysis to produce a highly viable mechanical.
• Create documentation, including component details, assembly details, incoming and finished inspection requirements, using CAD (Computer Aided Design) as a design tool.
• Responsible for all aspects of design documentation including requirements specification, engineering analysis, drawings, test plans/procedures, validation, the release of components, assemblies and products to production, and production start-up support.
• Supports the manufacturing engineering team in troubleshooting and resolving issues discovered during production.
• Be a self-starter, action oriented, organized and disciplined.
• Keep abreast of technical developments in own field through literature, technical contacts, and industry competition.
• Work in close co-ordination with PMG and manufacturing engineering for resolution of issues as they arise during sample build phases and actual production
• Lead & or support CAPA activities for closure of CAPA with effective implementation of containment, corrective and preventive actions.
• Lead RCA investigation for any issues arises in the plant or in the field using fish bone diagrams, probable and potential causes, why-why analysis, replicating issues in the lab and taking containment and corrective actions for re-occurrence prevention.
• To succeed in this role, you should have the following skills and experience
• Bachelor s or Master s degree in Mechanical or Mechatronics Engineering.
• Minimum of 6 years experience in the design and analysis of medical devices
• Experience in design and analysis of medical ventilators or medical gas delivery systems a plus.
• Experience leading a technical team in product development.
• In depth knowledge of pneumatic systems including pressure and flow sensing.
• Experience in the design and analysis of low and medium pressure gas valves.
• Experience with low pressure gas blowers.
• Experience with Computational Fluid Dynamics.
• Experience in the design of plastic injection molded parts.
• Knowledge of ASME (American Society of Mechanical Engineers) Y14.5 Dimensioning and Tolerancing.
• Proficiency with solid modeling CAD software (Pro-E/Creo a plus).
• Good mechanical aptitude and solid understanding of mechanical engineering principles.
• Effective communication skills, both oral and written.
• Familiarity with FDA (Food and Drug Administration (USA)) quality systems including ISO13485, 21CFR Part820 (a plus).
• Familiarity and experience with SAP, Windchill, MBSE tools, CITOL, Ansys WB would be added advantage

To succeed in this role, you should have the following skills and experience

• Bachelor s or Master s degree in Mechanical or Mechatronics Engineering.
• Minimum of 6 years experience in the design and analysis of medical devices
• Experience in design and analysis of medical ventilators or medical gas delivery systems a plus.
• Experience leading a technical team in product development.
• In depth knowledge of pneumatic systems including pressure and flow sensing.
• Experience in the design and analysis of low and medium pressure gas valves.
• Experience with low pressure gas blowers.
• Experience with Computational Fluid Dynamics.
• Experience in the design of plastic injection molded parts.
• Knowledge of ASME (American Society of Mechanical Engineers) Y14.5 Dimensioning and Tolerancing.
• Proficiency with solid modeling CAD software (Pro-E/Creo a plus).
• Good mechanical aptitude and solid understanding of mechanical engineering principles.
• Effective communication skills, both oral and written.
• Familiarity with FDA (Food and Drug Administration (USA)) quality systems including ISO13485, 21CFR Part820 (a plus).
• Familiarity and experience with SAP, Windchill, MBSE tools, CITOL, Ansys WB would be added advantage