Medical Device Specialist

3 weeks ago

Madison, United States Mallinckrodt Full time

Job Title

Medical Device Specialist

Requisition

JR000014193 Medical Device Specialist (Open)

Location

CC-Madison - USA503

Additional Locations

Madison, WI

**Job Description**:
The Medical Device Specialist will be involved in testing medical device assemblies, final products, and accessories based on provided manufacturing documentation. Responsibilities include diagnosing assembly issues, conducting repairs, and maintaining testing equipment with mínimal supervision. Ensuring compliance with company quality systems and medical device regulations is paramount throughout all tasks.
- Essential Functions- Follow established work instructions, policies, and procedures for assembling, testing, and repairing tasks.-
- Conduct assembly diagnosis and repair procedures as required.-
- Ensure timely completion of all training obligations.-
- Maintain a well-organized and professional workspace environment.-
- Utilize a variety of common hand tools and semi-automatic production equipment proficiently.-
- Promptly report any quality concerns to the area Supervisor or Team Lead.-
- Assist in training other production assemblers when necessary.-
- Demonstrate the ability to work diligently and remain focused on assigned tasks.-
- Exhibit strong hand-to-hand and hand-to-eye coordination skills.-
- Perform repetitive tasks while seated or standing for extended periods.-
- Operate in accordance with standard operating procedures (SOPs) and assembly drawings.-
- Follow written and verbal instructions accurately.-
- Maintain keen attention to detail while managing multiple tasks under tight deadlines.-
- Adhere to Environmental Health and Safety (EHS) and Quality procedures, regulations, and policies.- Minimum Requirements- 2+ years of experience in Medical Device cGMP manufacturing or equivalent manufacturing roles.- Ability to comprehend and interpret basic written technical information proficiently.- Proven track record of meticulous attention to detail and dedication to maintaining high-quality work standards.- Proficiency in communicating effectively using English (or the local language).- Flexible to work scheduled or extended shifts, holidays, and/or off-shift duties as required.

Desired Qualifications:
- Completion of a two-year technical degree program in electronics or an equivalent qualification.- Previous experience in a regulated medical device cGMP environment or equivalent field.- Proficiency in SAP software.
- Organizational Relationship/Scope:
This role will require cross-functional relationships with the Supply Chain team as well as the Engineering group as required.
- Working Conditions:
Clean, temperature-controlled environment.

LI-LM1

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