Medical Device Specialist

The Medical Device Specialist assembles medical devices and components within a controlled environment, ensuring compliance with strict quality and safety standards. This role requires strong attention to detail, manual dexterity, and the ability to perform more complex assembly tasks with increasing independence. Responsibilities may also include basic troubleshooting and supporting the training of new team members.

• Perform assembly of medical components using hand tools and fixtures.

• Follow written instructions, visual diagrams, and Standard Operating Procedures (SOPs).

• Conduct in-process inspections and report nonconformities.

• Maintain clean and organized workstations.

• Accurately complete production documentation and data entry.

• Monitor product quality and take corrective action when needed.

• Train and guide new team members on tasks and processes.

• Assist with continuous improvement initiatives.

• Comply with cGMP, ISO 13485, and company safety guidelines.

• Other duties as assigned.

• Associate's degree in a technical field.

• High school diploma or GED with 2-3 years in a regulated manufacturing environment, preferably medical devices.

• Familiarity with manufacturing documentation and adherence to quality standards

• Effective communication skills and a collaborative team mindset

• Ability to identify and escalate quality concerns promptly

• Clear and professional verbal and written communication abilities

• Capable of working independently while also contributing in a team environment

• Dependable, punctual, and dedicated to high performance

• Flexible and able to adapt to shifting priorities and responsibilities

• Strong organizational skills with the ability to manage time effectively

• Eagerness to learn and continuously improve performance

• Commitment to fostering a respectful and inclusive workplace

• Proven ability to follow established procedures with a keen eye for detail

• Ability to work scheduled or expanded shifts, holidays and/or off-shift duties, as necessary.

Preferred Qualifications:

• Experience working in a regulated medical device cGMP environment or equivalent.

• Experience with SAP or other ERP system.

This role will require cross-functional relationships with the Supply Chain team as well as the Engineering group as required.

Clean, temperature-controlled environment.

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