Biomedical Manufacturing Technician- Job post

CollaMedix Incorporated

11000 Cedar Avenue

Cleveland, OH 44106

Job details

Job Type: Full-time

Number of hires for this role: 1

Full Job Description

CollaMedix is a startup medical device company located on the Campus of Case Western Reserve University in Cleveland, OH. We are developing and manufacturing collagen-based medical devices for use in various orthopedic and surgical applications to enhance the body’s ability to heal and ultimately improve people’s lives.

We are seeking a self-driven, reliable and committed individual to help us manufacture and test these products.

In this role, the individual will be primarily responsible for the direct manufacturing of medical devices including (but not limited to):

• Follow work instructions to prepare collagen solution from collagen and various chemicals ingredients.
• Follow work instructions in setting up, running, and maintaining manufacturing equipment used to make collagen thread and braids.
• Manufacture CollaMedix’s collagen based prototypes and products.
• Perform and document quality checks and mechanical and analytical testing during the manufacturing process and offline.
• Perform preventative maintenance, calibrations and quality checks on critical equipment
• Perform mechanical and analytical testing during both the manufacturing process and offline
• Follow procedures and perform precision tasks consistently
• Accurately document procedures and tasks on the device history record (DHR) forms
• Communicate clearly with other departments to understand requirements and the role of manufacturing in meeting those requirements
• Maintain required manufacturing records and documentation per GMP and ISO 13485 guidance
• Participate in manufacturing process improvements
• Clean the equipment, lab areas, and labware

Qualifications:

Candidate Requirements and Desired Education and Experience:

• A High School Diploma/GED is required
• A 2 or 4-year technology degree in engineering or scientific field is highly desirable.
• Previous experience working in a laboratory, medical device or pharmaceutical company is highly desirable.
• Attention to detail, desire to learn, and the ability to complete the paperwork required for medical device manufacturing is important.
• Critical thinking with hands-on abilities and the ability to work independently or part of a team.
• High level organizational skills
• Basic proficiency with computers in Microsoft Word, Excel and Outlook

Language Skills: Candidate must have the ability to read, analyze and interpret general technical procedures and government regulations written in the English language. Must also be able to effectively respond to questions from their manager and other employees and ISO / FDA auditors in the English language.

Work Environment: Functions will be performed in a laboratory setting in both a sitting and standing position. When manufacturing collagen, the individual will be expected to wear designated gowning and follow standard anti-contamination practices. All areas are environmentally controlled.

Physical Requirements:

The individual will be expected to perform the following physical activities:

• Be able to stand or sit for extended periods of time.
• Be able to maneuver in a lab type environment.
• Pressing buttons adjusting knobs and typing on keyboards
• Placing product in packaging and operating heat-sealing equipment
• Moving containers and boxes weighing up to 25 lbs
• Completing forms and other basic paperwork.

Travel: Very limited to no travel expected.

Disabilities Discrimination: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this job description are representative of the knowledge, skill and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Job Type: Hourly, Full-time with benefits (medical, dental and vision). Simple IRA matched up to 3%.

Schedule:

• 8-hour shift

Work Location:

• One location

This Job Is Ideal for Someone Who Is:

• Curious and detail-oriented
• Functions well in a team environment
• Work Remotely: No

.

Job Type: Full-time

Pay: $19.40 - $23.36 per hour

Benefits:

• Dental insurance
• Health insurance
• Paid time off
• Vision insurance

Schedule:

• 8 hour shift
• Monday to Friday

Experience:

• GMP manufacturing: 2 years (Required)
• Manufacturing: 2 years (Preferred)

Shift availability:

• Day Shift (Preferred)

Work Location: In person