Is this you?
- Do you thrive on following standardized procedures that must be executed exactlyevery time?
- Are you comfortable working under close supervision with frequent review to ensure world-class quality?
- Do you enjoy assembling intricate partsoften under a microscopein a cleanroom environment?
- Can you keep meticulous records so every part remains fully traceable?
What the work involves
You’ll support a manufacturing cell building high-impact Class III devices: pacemakers, implantable cardioverter defibrillators (ICDs), leads, and related assemblies. Expect a blend of assembly, basic repair, and testing activities performed according to specified, standardized procedures. Your contributions feed directly into life-sustaining productsand that’s why your output is continuously reviewed for accuracy and conformance.
Your responsibilities
- Carry out routine assembly, repair, and testing per SOPs for pacemakers, ICDs, and lead systems.
- Maintain up-to-date travelers and quality documentation to ensure complete traceability.
- Communicate issues and solutions clearlyboth verbally and in writingto all levels of manufacturing management.
- Interact positively with internal partners and with external visitors (including customer or community tours).
- Follow safety rules rigorously and use required protective devices for each operation.
- Participate in continuous improvement and quality initiatives aimed at achieving quality and profitability metrics.
- Support Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements, including FDA/GMP expectations.
- Collaborate with your Supervisor/Manager to set and monitor personal goals and cell-level performance metrics focused on ongoing quality improvement.
How you’ll succeed
- Apply a basic understanding of Lean manufacturing to daily tasks.
- Use electronic data collection tools and software systems to capture and manage production data.
- Read and follow written procedures; understand and act on verbal instructions.
- Prioritize by sequencing tasks based on precedence and importance to meet deadlines.
- Manipulate small parts safely and accurately; make time-critical decisions with minimal supervision when needed within defined processes.
Minimum education
High school diploma or equivalent required.
Relevant experience
- Quality inspection
- Cleanroom production
- Electromechanical and electronic assembly
- FDA/GMP compliance
- Medical device assembly
- Microscope-based assembly
- Manufacturing production
