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 minimal 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

Mallinckrodt is a global specialty p harmaceutical business that develops, manufactures, markets and distributes specialty pharmaceutical products. Areas of focus include therapeutic drugs for autoimmune and rare disease specialty areas like neurology, rheumatology, nephrology, ophthalmology and pulmonology; immunotherapy and neonatal respiratory critical care therapies; and analgesics and central nervous system drugs. The company's core strengths include the acquisition and management of highly regulated raw materials; deep regulatory expertise; and specialized chemistry, formulation and manufacturing capabilities. The company's Specialty Brands segment includes branded medicines; its Specialty Generics segment includes specialty generic drugs, active pharmaceutical ingredients and external manufacturing.

To learn more about Mallinckrodt, visit www.mallinckrodt.com.

Mallinckrodt Pharmaceuticals (“the Company”) maintains a continuing policy of non-discrimination in employment. The Company is an equal opportunity employer and complies with all applicable laws prohibiting discrimination based upon age, ancestry, color, religious creed (including religious dress and grooming practices), disability (mental and physical), marital status, medical condition, genetic information, military and veteran status, national origin (including language use restrictions), political activities or affiliation, race, sex (including pregnancy, child birth, breastfeeding and medical conditions related to pregnancy, child birth or breastfeeding), gender, gender identity and gender expression, sexual orientation, as well as any other category protected by law. Furthermore, it is our policy to provide equal opportunity to individuals with disabilities and protected veterans in all phases of the employment process and in compliance with applicable federal, state, and local laws and regulations on every location in which the company has facilities. This policy of non-discrimination shall include, but not be limited to, the following employment decisions and practices: recruiting, hiring; promotions; demotions or transfers; layoffs; recalls; terminations; rates of pay or other forms of compensation; selection for training, including apprenticeship; and recruitment or recruitment advertising.

Mallinckrodt Pharmaceuticals is required to report certain payments or transfers of value (such as expense reimbursement, meals, transportation) made to U.S.-licensed healthcare professionals in compliance with the federal Physician Payment Sunshine Act (i.e. Open Payments) and certain state laws.