Hypo South Production Operator - D Shift

5 days ago Be among the first 25 applicants

This position will maintain the components in the mezzanine that feed the production line below. It will keep an up to date inventory of all components and ensure compliance with BD quality systems, policies, procedures and best practices, as well as all local, state, federal and BD safety regulations, policies and procedures. Regular, punctual attendance is an essential job function. Willing and able to uphold BD Values.

• Work as one of a team for maximum effectiveness and optimal task methods, which includes product inspection, operating equipment, raw material and finished goods movements and clean room area and equipment cleaning / sanitizing.
• Perform visual inspections
• Perform basic troubleshooting of equipment
• Perform changeovers, line clearance and cleaning.
• Achieve production rate and quality goals on assigned equipment
• Facilitate continuous operation of the equipment through breaks.
• Perform rework
• Cross train where needed within the department to support the business
• Maintain all quality and GMP standards
• Perform needed SAP data entries
• Participate on blitz teams as assigned
• Other duties as required to support the needs of the business

• High School diploma/GED preferred
• In lieu of High School diploma/GED, two years manufacturing experience is required

• Forklift experience preferred

• Ability to keep and maintain detailed documentation/communication - Proficient
• Teamwork – Proficient
• Organization skills – Basic
• Computer skills – Basic

We are the makers of possible

This role supports the development, manufacturing, and quality assurance of infusion therapy systems, ensuring compliance with medical device regulations and high standards of product reliability.

• Participate in the design, development, and testing of new infusion therapy products and enhancements.
• Conduct root cause analysis of product failures and implement corrective and preventative actions (CAPA).
• Collaborate with cross-functional teams including R&D, Manufacturing, Quality Assurance, and Regulatory Affairs.
• Develop and execute test protocols for product verification and validation.
• Support manufacturing operations by troubleshooting production issues and optimizing processes.
• Maintain accurate and detailed documentation in compliance with design control procedures and quality system regulations.
• Assist in the preparation of regulatory submissions and respond to agency inquiries.
• Conduct risk assessments and participate in FMEA (Failure Mode and Effects Analysis) activities.
• Provide technical support for existing product lines and address customer inquiries.
• Stay current with industry trends, regulatory changes, and technological advancements in infusion therapy.

• • Bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific discipline.
• • Minimum of 2 years of experience in the medical device industry, preferably with infusion therapy systems.
• • Strong understanding of medical device regulations (e.g., FDA 21 CFR Part 820, ISO 13485).
• • Experience with design control, risk management, and CAPA processes.
• • Proficiency in data analysis and statistical methods.
• • Excellent problem-solving, analytical, and critical thinking skills.
• • Strong written and verbal communication skills.
• • Ability to work independently and collaboratively in a team environment.
• • Experience with CAD software (e.g., Solid Works, AutoCAD) is a plus.

• Competitive pay
• Access a portion of your pay before pay day with Daily Pay
• Healthcare coverage:
  No paycheck contributions for eligible associates under a certain salary threshold enrolled in the HSA Basic Medical Plan option, no matter how many dependents you cover.
• Preventive care covered at 100%.
• Dental and vision insurance at group rates.
• Paid parental leave up to 6 weeks
• Adoption assistance plan
• 401(k) plan with 75 cents on the dollar matched by BD up to 6% of compensation
• Company paid…