Medical Device Assembler I

Acist Medical Systems Inc.; Eden Prairie (MN); On-site; USD 35,000 - 45,000; Full time

Job summary

Acist Medical Systems Inc. in Eden Prairie, Minnesota is seeking a Medical Device Assembler I responsible for the assembly and testing of electro-mechanical medical devices. The role requires following established work instructions and compliance with quality system procedures.

The ideal candidate will have a high school diploma, 1+ years of experience in electro-mechanical assembly, and the ability to handle small components and lifting up to 45 lbs. This position offers an opportunity to work in a collaborative environment aimed at continuous process improvement.

Qualifications

• Minimum 1+ years of electro-mechanical assembly experience.
• Ability to lift and package assemblies weighing up to 45 lbs.
• Preferred: 3+ years of assembly experience in medical devices.

Responsibilities

• Assemble and test product from components to finished goods.
• Generate Quality System Records as required.
• Participate in continuous improvement processes.

Skills

Electro-mechanical assembly

Mechanical assembly tools

Problem-solving

Teamwork

Documentation maintenance

Education

High School diploma or equivalent

Tools

Measurement equipment (DMM, caliper, micrometer, oscilloscope)

MS Word

Excel

MRP Systems

Job description

The Medical Device Assembler I is responsible for performing a variety of production tasks related to the assembly and testing of electro‑mechanical medical devices. Utilizing established work instructions and SOP’s, this individual will assemble electromechanical equipment, from components to finished goods. All tasks are completed in accordance with the ACIST Medical Systems/Bracco Medical Technologies Quality System, Standard Operation Procedures (SOP), Work Instructions (WI), Engineering Prints and Bills of Materials (BOM).

Primary Duties & Responsibilities

• Follow established work instructions to assemble and test product from components to finished goods – to meet customer demand and verify design specification requirements
• Generate Quality System Records on applicable ACIST/BMT documentation as required
• Perform timely transactions online utilizing ERP/MRP system
• Understand and comply with ACIST Medical/BMT Quality Policy, ESD precautions, and OSHA guidelines as applicable
• Participate in continuous improvement by assisting ACIST/BMT personnel with process, documentation and material improvements
• Other duties or projects as required

Qualifications (Knowledge, Skills & Abilities)

• Minimum High School diploma or equivalent
• Minimum 1+ years of electro‑mechanical assembly experience, including experience with mechanical assembly tools
• Demonstrated ability to follow documented manufacturing processes (i.e. written work instructions), including problem solving
• Ability to maintain accurate documentation (e.g., record traceability information onto routers, and transact materials online)
• Ability to handle multiple tasks simultaneously
• Ability to work effectively in a team environment and contribute to maintaining positive interpersonal relationships and foster cooperation within and outside the department
• This position requires the physical ability to assemble small components using manual hand tools, and the ability to lift and package medical device assemblies weighing up to 45 lbs
• Preferred: 3+ year(s) electro‑mechanical medical device assembly experience
• Knowledge of Good Manufacturing Procedures (GMP’s), ISO regulations, and Quality Systems as it pertains to hardware manufacturing at Medical Device Manufacturers
• Demonstrated experience utilizing measurement equipment (i.e. DMM, caliper, micrometer, oscilloscope)
• Moderate level of computer proficiency including MS Word, Excel, Outlook, MRP Systems and database systems