Biomedical Specialist

Indotronix Avani Group; Madison (WI); On-site; USD 45,000 - 65,000; Part time

Job summary

A leading medical equipment manufacturer in Madison, Wisconsin is seeking an Associate with experience in assembling and testing medical devices. The ideal candidate will have a background in engineering and knowledge of quality systems. Responsibilities include the assembly and diagnosis of medical device products, as well as contributing to the development of operational documentation. This role offers a contract employment type and a chance to work in a regulated environment.

Qualifications

• Bachelor’s degree in engineering or related field required.
• Experience in manufacturing or similar position preferred.
• Knowledge of cGMP and quality documentation standards is essential.

Responsibilities

• Assemble and test medical device products according to documentation.
• Perform diagnosis, repair, and testing with supervision.
• Develop and revise Standard Operating Procedures (SOP).

Education

Bachelor’s degree in engineering or a related scientific field

Associate’s degree with 2+ years’ experience

High School Diploma with 6+ years of experience

Tools

SAP

Job description

Essential Functions

• Assemble and test medical device assemblies, final products, and accessories per the manufacturing documentation provided.
• Perform assembly diagnosis, repair, and test equipment maintenance with supervision. Ensure work is completed in compliance with the company quality system and medical device regulations.
• Assemble, test, and repair work per established work instructions, policies and procedures.
• Performs assembly diagnosis and repair.
• Notify the area supervisor and/or team lead of quality concerns.
• Operating within standard operating procedures (SOPs) and assembly drawings.
• Provide guidance in problem diagnosis and resolution with team members.
• Assist in the development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI), and Device History Records, or other quality documentation, as necessary, to support production processes.

Education / Experience / Skills

• Bachelor’s degree in engineering or a related scientific field. Associate’s degree with 2+ years’ experience or High School Diploma with 6+ years of experience in a similar position.

Desired Qualifications

• Experience working in a cGMP setting and controlled documentation, SAP, and Six Sigma belt, or LEAN ideology.

Seniority level

• Associate

Employment type

• Contract

Industries

• Medical Equipment Manufacturing, Pharmaceutical Manufacturing, and Biotechnology Research