What are the responsibilities and job description for the Manufacturing Operator II position at 4 C Medical Technologies?
Description:
Company Overview:
We are a small but mighty, well-financed team dedicated to proving the effectiveness of our life enhancing, live saving therapy. 4C Medical Technologies, Inc., is developing the first Mitral Valve Regurgitation therapy to expand the treatable patient population and streamline the procedure. Our Alta Valve is currently in the clinical trial phase of FDA approval.
Job Summary:
In this full time temp to hire role, the primary responsibilities is to assemble state of the art transcatheter mitral valve replacement (TMVR) delivery systems.
Key Responsibilities:
- Build/assemble medical devices by following all manufacturing procedure requirements.
- Build/assemble delivery systems and reflow materials – process training will be provided.
- Follows company/department policies and guidelines, including but not limited to, clean room adherence, company attendance and safety policies.
- Collaborate with operations leadership to manage, communicate and execute build priorities and schedule to meet company goals.
- Be flexible with multiple roles, rotating as necessary, and work well with direct and cross-functional team members.
- Maintain accurate records, including training files and Device History Records (DHRs).
- Identify and report process and/or material issues.
- Provide feedback to improve processes and assembled product quality.
- Work with the aid of a microscope.
- Work overtime when and if expected.
Education:
- High School Diploma, or equivalent
Experience:
- Three plus (3 ) years’ experience working in medical device manufacturing and/or process development.
Knowledge, skills and abilities:
- Ability to follow complex, multi-step work procedures.
- Ability to tolerate and follow gowning, sanitation, other procedures for working in a clean room environment.
- Ability to work with the aid of a microscope.
- Ability to work overtime when expected.
- General knowledge of basic inspection equipment (Laser mic, calipers, drop gages, etc.)
- Excellent written communication, self-motivation, organizational, and interpersonal skills.
