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Manufacturing Operations Manager - Medical Device, Respiratory


CyberCoders


Location

Santa Ana, CA | United States


Job description

If you are a Manufacturing Operations Manager - Medical Device with experience, please read on!

Based in Irvine, CA, we are an exciting, growing startup in the medical device respiratory space. We have a headcount of about 25 and looking to expand and accomplish big goals in 2024. Due to growth, we are looking for a talented Manufacturing Operations Manager to join us in a leadership role to oversee manufacturing and production in our facility in Irvine. We recently obtained FDA approval for our flagship product and are ready to ramp-up production for it to be sold all around the world.

Apply today! We are actively interviewing for this highly visible role.

Top Reasons to Work with Us

**This role is ONSITE in Irvine and candidates must be able to work onsite in Irvine 5x a week.**

What You Will Be Doing

As the Manufacturing Operations Manager, you will be responsible for contributing to the design, development and manufacturability of specific product(s) in accordance with the companys Quality System and customer requirements. This position will ensure that assigned projects and/or product(s) are designed for technology transfer from R&D to manufacturing and facilitate improved manufacturability. This position complies with the Quality System by engaging in appropriate levels ISO test methodologies, adherence to Quality System Design Controls, and applies proper documentation skills.

What You Need for this Position

5+ years of experience in the following:

- Medical Device - Class II or III
- cGMP - ISO - MDD
- AutoCAD - SolidWorks - Pro E software
- FDA Clearance and Compliance

- Manufacturing Operations
- People Management
- Product Testing & Data Collection

- Design Control procedures and requirements
- Engineering - Biomedical Engineering degree
- Startup experience a plus

What's In It for You

- Competitive Base Salary: $150,000 - $170,000 DOE
- Stock Options / Milestone Bonuses
- Medical (100% employee paid)
- Dental / Vision insurance
- Flexible Time Off
- 401k plan
....and more perks!

So, if you are a Manufacturing Operations Manager - Medical Device with experience, please apply today!

Applicants must be authorized to work in the U.S.

Preferred Skills

AutoCAD - SolidWorks - Pro E software

Medical Device - Class II or III

cGMP - ISO - MDD

FDA Clearance and Compliance

Manufacturing Operations

People Management

Product Testing & Data Collection

Design Control procedures and requirements

Engineering - Biomedical Engineering degree

Startup experience a plus


Job tags

Full timeFlexible hours


Salary

$150k - $170k

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