Product Engineer
JOB TITLE
Product Engineer
DEPARTMENT
Engineering
ACCOUNTABILITY
Engineering Manager
DIRECTLY RESPONSIBLE FOR
Nil
PURPOSE OF JOB
The incumbent will be responsible for the design change controls and product sustaining engineering initiatives. He / She shall ensure that the product designs are validated per customer requirements, including domestic and international regulatory standards.
Utilize technical, project and leadership skills in the development, improvement and optimization of critical care products such as transducers and catheters. Apply technical principles, theories and concepts, as well as problem solving capabilities to resolve product design issues.Maintain design history files, determine test methods requirements, design verification, perform failure mode effect analysis and implement product-related solutions that improves performance and/or quality, as well as address shelf life requirements.
Provide technical support for existing products with issues relating to regulatory compliance, customer complaints, process improvement and CAPA resolution.
Keep abreast of potential new technologies to enable the design of new materials and capabilities. Leverage existing technologies to advance our core businesses while supporting the development of new products.
JOB FUNCTION- Participate in Product Engineering efforts to validate / verify product design per customer requirements.
- Manage cost of sustaining engineering projects assigned.
- Make timely reports of progress, noting deviations from time or cost plans or customer design requirements.
- Coordinate development efforts with packaging engineering, process engineering, and all other departments that participate in product development.
- In own field of scientific / engineering competence, maintain up-to-date familiarity with developments through attendance at professional meetings, literature and consultations.
- Assist in anticipating, answering and alleviating any customer dissatisfaction with a product.
- Support cost reduction programs and provide technical line support for existing product lines.
- Establish / maintain a base of knowledge of customer requirements through literature, customer visits, etc.
- Comply with all local, state, federal, and Merit safety regulations / policies / procedures.
- Comply with all quality policies / procedures / practices through consistent application of sound Quality Assurance principles.
- Other projects as assigned.
- Internal communication with all levels of associates.
- External liaison with inter-companies, customers and vendors.
- Degree in Bio-Medical / Mechanical / Electrical Engineering.
- Minimum 3 years’ experience of product / process engineering in a medical device company or related industry.
- Experience in product design with thermoplastic knowledge, preferably in medical device industry, will be an advantage.
- Knowledge in CAD Design / SolidWorks and statistical methods.
- Excellent interpersonal and communication skills.
- Knowledge of U.S FDA regulations, the Medical Devices Regulation (2017/745), ISO 13485 Quality System Standard, ISO 14971 Risk Management are an added advantage.