New product design & development initial stage to production stage.
Benchmarking of the product.
Test and record performance of components, products & manufacturing methods.
Analyze and resolve technical issues associated with components, products, manufacturing methods and performance.
Prepare bill of materials (BOM), design specifications & raw materials specifications etc.
Conduct failure mode & risk analysis according to ISO 13485.
Responsible for product design verification & validation and maintain its records.
Ensuring Manufacturing performance and Quality goals are met.
Prepare and review documentation history files (DHFs). .
Maintain and improve existing product manufacturing processes. Anticipate Manufacturing’s need for new products and fixtures.
To be involved in the assembly, troubleshooting, testing, and repair activities of our products.
Provide instruction and support to Manufacturing and QA on manufacturing techniques, procedures, and QC inspections.
Survey and identify replacement components for reasons of obsolescence or cost reduction.
Identify and contact vendors. Compare technical specifications. Compile and prepare required documentation.
Assure the timely manufacturing, packaging, and delivery of new products.
Identify, source, and implement improvements in manufacturing procedures.
Coordinate relationships with vendors and contractors.
Responsible for on-going process improvement: take initiative to define, plan, and execute improvement projects, achieve objectives in increasing yields, reducing cycle time, reducing overall cost, and improving product quality and reliability.
Education
Butcher of Engineering or Equivalent
Experience
Required minimum 5 year experience in medical device industries.
Knowledge and Training
Strong knowledge of medical devices product design and development process.
Knowledge of injection multi cavity injection mould, die, fixture and machine design.
Knowledge of design and drawing change control procedure.
Ability to assess the feasibility of design modifications to existing designs.
Experienced in troubleshooting and recommending corrective or preventive actions to improve product reliability.
Experienced in interfacing with functional groups outside of engineering
Good communication skills, verbal and written
Knowledge of ISO 13485 / MDR 2017
Strong interpersonal and collaborative skills. Works well as a supportive team member.
Knowledge of CAD software Solid Works is desirable.