Benefits:

401(k) matching

Company parties

Competitive salary

Dental insurance

Free food & snacks

Health insurance

Opportunity for advancement

Paid time off

Training & development

Vision insurance

BridgeMed Solutions, Inc is seeking a Operations Manager. Training will be provided.

Are you passionate about pioneering medical innovations? Join our dynamic team at BridgeMed Solutions, where we're revolutionizing healthcare through cutting-edge technology. We are an Irvine-based Contract Manufacturing Organization that is ISO and FDA certified. We are a privately owned company that specializes in tissue heart valve technology. We additionally custom produce transcatheter valves for various clients. Embrace the opportunity to make a meaningful impact on patient care while collaborating with talented professionals in a fast-paced startup environment. Apply now and be part of our journey towards transforming lives.

The Operations Manager should have a background as an engineer with general knowledge of engineering principles and be responsible for providing engineering support for products from design through commercialization.

Job Title: Project Manager

Experience: 2-4 years valve assembly experience, 5+ years of medical device experience

Location: Irvine, CA

Job Type: Full Time, 100% In-House

Salary: $60000 - $80000

Benefits: PTO, Sick days, Holiday Pay, 401k, Health-Vision-Dental Coverage, Free Lunch Fridays, Company Parties

Position Responsibilities

· This position will provide support in the design, development, testing, and refinement system, sub-system, and components for medical devices, manufacturing equipment, etc.

· Design and develop medical devices, and procedures using the principles of engineering and biological sciences

· Design, development, and verification/validation testing of medical products for CE mark submissions / FDA submissions

· Research, document, organize, prepare, and present the materials for internal knowledge transfer

· Accountable for all record-keeping as necessary

· Manage product design during product development

· Develop and control prototypes, laboratory testing, design refinement, design verification/validation, and documentation

· Perform necessary engineering analysis as-needed basis.

· Prepares plans, and schedules, and manages projects.

· Vendor and client management

Basic Qualifications:

B.S. degree in Mechanical Engineering

Heart Valve assembly is a must

3+ years of client management

3+ years of design and development

Oral and written communication skills

Solidworks / Cadcam is a plus

Vendor relations is a plus