CardioMed Supplies Inc., a therapeutic medical device manufacturer, and distributor located at Lindsay, ON, Canada, is looking for a versatile and responsible individual to join our R&D department as Research and Development (R&D) Engineer.
The desired candidate must have a minimum Bachelor’s degree in Applied Science and Engineering from an accredited university in order to be considered for the position. Mature candidate must have a minimum 3-year working experience in engineering functions (clinical research, data analysis, product development, system maintenance, manufacturing process, and quality assurance, etc.) of medical device manufacturing or pharmaceutical industry.
The position is full-time permanent. It aims of developing the skills in three major orientations: Product Research & Development, Manufacturing Process Support, and Quality Assurance & Regulatory Compliance Support for the candidate who would like to pursue a long-term career in the medical device industry.
The position will require re-location.
- Reporting primarily to the R&D Supervisor, the R&D/Quality engineer will
- Research and design new products within the scope of production in the field of Anesthesia, Hemodialysis, Cardiovascular and Oncology
- Identify new potential for product development by working along with external and internal partners, such as identifying new component from a new supplier
- Participate in the supplier qualification process based on design requirements and existing standards according to the procedure.
- Assist in the technical document preparation and control for the product
- Perform risk analysis, risk mitigation and risk management for the product and the process
- Conduct validation test for product design, manufacturing process, and manufacturing equipment
- Preparing production and quality assurance document including but not limited to: raw material specification for product instruction for use, and label
- Support product marketing activities by providing sample assembly, product costing, post-market surveillance inquiry, and product function inquiry as required by customers
- Responsible for equipment installation, validation, verification, and preventative maintenance
- Identify, document and implement training needs for applicable CardioMed staff upon implementing any design change or introducing new devices in the cleanroom
- Execute and maintain design control for the product development process
- Conduct other technical tasks as required
- Facilitate Quality Assurance tasks as needed.
- Must be able to work in Canada legally
- Minimum Bachelor Degree in Applied Science and Engineering in an accredited University
- 3 years of working experience as an engineer function
- Previous working experience in the medical device or pharmaceutical companies is preferred
- Must be a critical and independent thinker
- Excellent communication skills in verbal and written English
- Excellent adaptive and analytical skill
- Must be able to work within a team environment and independently
- Advanced computer programming skills in VBA, Python or C
- Advanced drafting software skills with SolidWork, AutoCAD, etc
- Proven organization and time management skills
- Must be able to multitask in cross-functional duties
- Self-motivated and result-driven
- Familiar with ISO9001 standard system and GMP
- P.Eng designation is an asset
- CQE designation is an asset
- Previous experience in Quality Assurance and Regulatory Compliance is an asset.
- Previous experience in ISO13485 environment is an asset
- The public commute is limited around the proximity. A full G license will be needed.
All Candidates will be required to send their CV to [email protected].
We thank all candidate who applies, however only selected candidate will be contacted for interview.