Scope of Work:
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 company quality system and medical device regulations.
Essential Functions
• Assemble, test, and repair work per established work instructions, policies and procedures.
• Performs assembly diagnosis and repair.
• Responsible for successful completion of all training in a timely fashion.
• Maintain an organized and professional workspace.
• Notifies area Supervisor and or Team Lead of quality concerns.
• Capability to train other production assemblers as needed.
• Operating within standard operating procedures (SOPs) and assembly drawings.
• Communicate with quality and facilities any time there is an issue with the product or equipment.
• Provide guidance in problem diagnosis and resolution with team members.
• Assist in development and revisions of Standard Operating Procedures (SOP), Work Instructions (WI) device history records, or other quality documentation, as necessary, to support production processes.
• Strong attention to detail, while multi-tasking under strict deadlines.
• Comply with EHS and Quality procedures, regulations and policies.
• Ability to work scheduled or expanded shifts, holidays and/or off-shift duties, as necessary.
• Other duties as assigned.
Minimum Requirements
Education / Experience / Skills:
• Bachelor’s degree in engineering or related scientific field. Associate’s degree with 2+ years’ experience or High School Diploma with 6+ years of experience in similar position.
• Ability to work independently and motivate staff to meet required deadlines.
• Problem solving and process improvement skills.
Desired Qualifications:
• Experience working in cGMP setting and controlled documentation
• SAP skills and experience.
• Six Sigma belt or LEAN ideology.
Organizational Relationship/Scope:
This position has achieved more advanced troubleshooting and diagnostic ability related to product performance and may be assigned other more advanced job tasks.
This role will require cross-functional relationships with the Materials group as well as the Engineering group as required.
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