Disposable Device Technician

3 weeks ago

Mississauga, Canada Profound Medical Full time

Our mission is to Profoundly change the standard of care by creating a tomorrow where clinicians can confidently ablate tissue with precision; a tomorrow where patients have access to safe and effective treatment options, so they can quickly return to their daily lives. Changing the standard of care is part of our fabric. We are a group of energetic, problem-solvers focused on innovation, and looking to change the world. We are changing the paradigm for treating diseases such as prostate cancer by using real-time MR Imaging, thermal ultrasound and close-loop temperature feedback control, to gently ablate the diseased tissue with mínimal side effects.

If you share our values and want to work in a collaborative results focused culture and want to make a Profound impact in healthcare and your career, here is your chance.

**General Accountability**:
Profound Medical assembles its medical device disposables in house within a clean environment. The Disposable Device Technician will be heavily involved in this activity, as well as the supporting the assembly of other medical devices as required by the business.

The Disposable Device Technician is responsible for building, testing and documenting sub-assemblies and top-level integration for Production. Disposable manufacturing is the assembly of mechanical components using epoxies.

The Disposable Device Technician works with Manufacturing, Engineering, and Supply Chain to ensure product is produced on time and according to specifications.

The Disposable Device Technician is responsible for the care and maintenance of the assembly area and associated equipment.

The Disposable Device Technician is also responsible for ensuring all equipment and test fixtures are calibrated on schedule, and that raw materials are stored safely, properly, and clearly identified.

The Disposable Device Technician will flex to support the other Medical Device Assembly responsibilities and will be cross trained as required to support business requirements.

The Disposable Device Technician acts as an incoming inspector as needed to support the business, can also serve as a receiver and inventory clerk for all production goods into and out of the Company. On occasion, this will include supporting the receiving and inspection of returned product, which needs to be investigated for errors, and reworked to production condition.

**Duties and Responsibilities**:

- Assemble mechanical components, test, and document all top-level product and sub-systems for production use by Customers
- Maintain the assembly area and all associated equipment, including ensuring proper cleanliness for bioburden testing
- Perform final integration and testing of top-level product based on instructions, as well as electrical safety testing of product before final shipping
- Flex to support other Medical Device Assemblies
- Provide support and feedback to quality and manufacturing engineering
- Support Lean and Health and Safety Initiatives
- Prepare and handle chemicals for use in the assembly process
- Receive and inspect incoming materials for workmanship standard, and quality compliance
- Ensure all product is built and tested according to the documented procedures, and all forms are completed correctly

**Education and Certification**:

- Post-Secondary diploma required.
- University or college degree in a technical area such as Mechanical/ Electronics/ Electro-Mechanical Technology or Engineering with Mechanical/ Electronics background preferred.

**Key Attributes (experience, skills and technical knowledge)**:

- 1+ year of manufacturing experience in a regulated environment (ISO 9001) performing intricate (high dexterity) manufacturing, preferably in the medical device industry (ISO 13485)
- Exposure to test equipment such as hi-pot, current leakage tester, and pressure leak tester
- Ability to use common shop tools
- Exposure to use of common mechanical measuring equipment
- Logical thinking with creative problem-solving ability
- Excellent written and verbal technical communications skills
- Detail-orientated, highly motivated, patient and diligent
- Able to work well in teams and independently
- Experience working with MR compatible devices and therapeutic ultrasound devices is an asset
- Knowledge of good manufacturing practices

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