JOB DESCRIPTION
Job Title: Medical Device Assembler
Department: Research & Development
Reports To: Research & Development Director
Position Summary:
Responsible for assembling, documenting, and verifying product
Authorities:
- Interface with vendors, order parts, materials. Support Manufacturing and R&D goals.
Duties and Responsibilities:
- Assemble products in full compliance with the company’s Design Control requirements and consistent with FDA QS Regulation, ISO, MDD, CE Mark, and Canadian Medical Devices
Regulations.
- Responsible for ensuring proper documentation consistent with company’s quality system.
- Responsible for knowing activities consistent the company’s quality policy and quality objectives.
- Responsible for ensuring the lab notebooks are documented in a timely manner and consistent with the applicable SOP.
- Build and test prototype designs for proof of concept.
- Perform product verification and validation testing.
- Perform process-related tasks to support pilot manufacturing.
- Support production of final product.
- Responsible for component documentation
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Maintain clean and orderly work/ lab space.
Position Requirements:
- Must possess good interpersonal and communication skills, and work in a collaborative style.
- Good technical skills
- Must be familiar with standard machine shop equipment
Education Requirements:
- High School degree or equivalent is required.
Experience Requirements:
- Minimum 0-1 year of experience in engineering preferably in the medical device and/or pharmaceutical.
Preferred Requirements:
- Has experience with soldering and handling electrical equipment
- Owning a car is preferred.
Note: This job description is an outline of the major recurring responsibilities of the job/position. It is not intended to be all-inclusive of the work to be performed. Other related job objectives, special assignments and less significant responsibilities will typically be performed by the incumbent. Incumbents will follow any other instructions, and perform any other related duties, as may be required by their supervisor.
Job Type: Full-time
Pay: From $31.25 per hour
Expected hours: 40 per week
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
Schedule:
Work Location: In person