Senior Manufacturing Technician

The primary initial function for the Senior Manufacturing Technician is to support Operations in the development, validation, maintenance and ongoing optimization of a new medical device manufacturing line. This position will eventually lead and perform manufacturing activities for clinical and commercial products and will be responsible for training new technicians based on production demand. It requires a broad skillset including manufacturing of medical devices, operator training, manufacturing build coordination, and process/equipment troubleshooting.

• Lead and support setup, maintenance, and troubleshooting of manufacturing processes, fixtures, and equipment.
• Identify risks and improvement opportunities during early line startup.
• Collaborate with Manufacturing Engineering on fixture design, equipment selection, procurement, and installation.
• Support process characterization and validation activities, including data collection, analysis, and documentation.
• Manufacture clinical and commercial medical device products in accordance with approved procedures and quality system requirements.
• Serve as a subject matter expert (SME) for assigned manufacturing processes during early production ramp and steady‑state manufacturing.
• Train and mentor manufacturing technicians and operators to ensure consistent, compliant execution of manufacturing processes.
• Ensure all manufacturing activities are performed in compliance with ISO 13485, FDA Quality Management System Regulations (21 CFR 820), and internal procedures.
• Support investigations of nonconformances related to manufacturing processes.
• Utilize measurement tools and inspection equipment to collect data and support process monitoring and improvement efforts.
• Respond to and resolve line‑down events with a sense of urgency.
• Perform minor equipment maintenance as needed.

• High School diploma or equivalent.
• Associate’s degree, technical certification, or equivalent combination of education and experience (preferred).
• 5+ years of experience in hands‑on manufacturing or process development within a highly regulated industry (medical device strongly preferred).
• Demonstrated success in launching new products and/or improving manufacturing processes.
• Ability to read/interpret manufacturing procedures and other technical documentation.
• Ability to work in an onsite, cleanroom manufacturing environment.
• Introductory knowledge of statistical tools and improvement techniques (SPC, DOE, Lean/Six Sigma) preferred.
• Strong communication skills with the ability to work effectively in a fast‑paced, collaborative environment.

1) Physical demands:

While performing the duties of this job, the employee is occasionally required to walk; sit; use hands to finger, handle or feel objects, tools, or controls; reach with hands and arms; balance; stoop; talk and hear. Specific vision abilities required by the job include close vision and distance vision. Ability to occasionally lift and/or move up to 35 pounds.

2) Work environment:

Will work in an ISO class 8 cleanroom manufacturing environment with gowning requirements. While performing the duties of this job, the employee will experience in/out of the office noise at a minimal level. Must be capable of transporting self to various business locations infrequently. If you use your own motor vehicle, you must have a current, valid state driver’s license and proof of insurance coverage that at least meets current residence’s state minimum requirements.

US and OUS travel may be required, but is not anticipated.