ISO 13485:2016 Certified - FDA Registered

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Medbio strives to provide premier contract manufacturing services to the medical and biotechnology industries. By leveraging the latest technology and production equipment, Medbio is able to provide innovative manufacturing solutions and maximize customer satisfaction. In addition to the constant bettering of our manufacturing operations, Medbio is dedicated to achieving the highest level of employee satisfaction. We achieve this by creating a work environment for our associates that encourages individual development, while providing opportunities to share ideas and cultivate teamwork.

Interested in Working for Medbio?

View our job postings below and if you are interested in a career at Medbio, email us your resumé and cover letter.

Quality Engineer

Summary of Functions:

The Quality Engineer (QE) primarily supports the customers to field any complaints or corrective action requests, and supports Engineering activities at Medbio. The QE will assist in, as necessary, production, metrology, and auditing activities, while preserving relevant ISO/cGMP requirements.

Major Duties and Responsibilities:

  • Learn and follow ISO/FDA requirements, ensuring that the procedures and systems at Medbio are in compliance; help maintain a high level of awareness of the requirements among the employees at Medbio.
  • Field any Customer Complaints and Supplier Corrective Action Requests (SCARs) and record them in their respective Logs. The QE will work with others in the organization to drive toward root-cause identification and solid, well-documented actions to prevent recurrence.
  • Assist Engineering in the planning and writing of protocols, and the execution (i.e. evaluation of parts) where necessary.
  • Assist Engineering in the brainstorming and recording portions of the risk analysis process, including Decision Tree Matrix (for protocols), PFMEA, Process Flow, Control Plans (when requested by the customer), and maintenance of any existing PFMEAs.
  • Review production documentation and ensure completeness and accuracy, and compliance of the production records to the SOPs. Assist in writing Communication Travelers, as necessary, to clarify or enhance the production specifications.
  • Create MRBs, as necessary, and assist in the investigations and disposition of suspect material, whether from internal or external sources.
  • Provide input to all QA-related IQMS procedures and qualification efforts; provide necessary training and training literature for new modules.
  • Provide backup support to the V.P. for the review and sign-off of Protocols and Reports, as well as for DCNs, Temporary Deviations, and other related authorizations.
  • Assist the V.P. in the review of Mold Qualification results, for dimensional results and/or general paperwork submissions to customers.

Organizational Relationships:

The QE reports directly to the V.P. of Quality Assurance and Regulatory Affairs. Management and technical staffing can look to the QE for clear resolution to specification and/or part-quality issues. Engineering will regularly partner with the QE for measurement systems analysis, risk analysis, or qualification activities

Experience and/or Educational Requirements:

  • Four-year degree or equivalent in years’ experience in Quality-related field
  • Two years or more involved in plastic injection molding
  • Preferred experience in a medical device manufacturing environment
  • Understanding of ISO/FDA requirements with regard to manufacturing and document control
  • Good computer skills (Microsoft Office)
  • Good blueprint reading skills; GD&T experience a plus
  • Very strong written/verbal communication, leadership, interpersonal and motivational skills
  • Self-motivation and ability to manage the QE’s portion of complex projects with important deadlines

Physical Requirements:

Must be able to work and perform what would be considered standard for this type of position in the industry.

Plastic Injection Molding Machine Operator — 2nd & 3rd Shift

Summary of Functions:

Responsible for part production; molding, assembly, and inspection of all product produced.  The selected candidate will have excellent vision, hand eye coordination, dexterity, and analytical skills with a high focus on organization, cleanliness, ability to follow procedures, and quality of work.

Major Duties and Responsibilities:

  • Able to retrieve product from molding machines; both automatic and manual at standard rates
  • Able to visually inspect and measure all parts according to specifications and blueprints
  • Able to perform assembly work at the standard rate and meet all quality expectations
  • Must follow all specifications, department procedures, and all ISO/GMP’s
  • Must be able to work as a team with other Operators and Support Staff
  • Must understand department goals and objectives as well as participate in advancing them

Organizational Relationships:

This position will directly report to the Molding Team Leader.  There will be frequent interaction with Technicians, and Quality personnel, as well as regular interactions with engineering.

Experience and/or Educational Requirements:

  • High School Diploma or equivalent
  • 2-5 years experience in fast paced environment of medical device molding and assembly
  • Strong communication and teamwork skills
  • Strong analytical skills
  • An orientation toward process improvements
  • Able to read and write fluently as well as read basic blueprints and dimensional callouts

Physical Requirements:

Must be able to work a standard 40-hour workweek with occasional overtime including weekends a possibility.  Sitting and/or standing for extended periods of time as well as some walking within the facility.  Must be able to see with or without corrective lenses and distinguish color differences and depth perception for product and safety issues.  Hearing ability should be sufficient to hear and react to audible alarms from distances up to 100 feet.  The ability to lift and carry various items up to 50 pounds.

Injection Mold Design Engineer

Summary of Functions:

We are looking for someone to fill a dynamic and challenging position as an Injection Mold Design Engineer. We provide innovative solutions to our customers, while offering an exceptional level of support.

The successful candidate for the Injection Mold Design Engineer position must be especially detail oriented. This position will provide support for all manufacturing facets, including CNC and EDM departments, lead mold-makers, and program management staff. This position will also support the sales and management staff by providing information necessary for engineering change reviews and new mold quoting.

Major Duties and Responsibilities:

  • Communicating with customers to work through DFM concerns
  • Following specific tooling standards to create comprehensive 3D mold designs
  • Creating 2D mold layout assembly drawings and bill of materials
  • Creating 2D drawings of all manufactured components
  • Generating 3D electrodes, along with 2D detail drawings and burnsheets for EDM
  • Overlaying part models and providing information for engineering changes
  • Ordering mold bases, hot-runner systems, and standard components
  • Oversee several new mold designs at all times

Experience and/or Educational Requirements:

  • High-school diploma required
  • Journeyman Mold-Maker certificate preferred
  • Associate degree in Computer Aided Design or Machine Tool Technology preferred
  • Minimum 3-5 years experience with Cimatron and/or SolidWorks for modeling, drafting, and detailing
  • Minimum 5-10 years experience directly related to injection mold building and design
  • Strong computer skills with knowledge of Microsoft Office
  • Excellent people and communication skills
  • Excellent organization and documentation skills

Physical Requirements:

Must be able to work and perform what would be considered standard for this type of position in the industry.

Innovative.  Trustworthy.  Knowledgeable.  Passionate.
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