Senior Quality Assurance Engineer

Corindus Inc. is a well funded, growing, early stage medical device company which has developed a unique robotic system to be used during percutaneous procedures in the cath lab. The company is establishing a new standard for the physician quality of life, workflow efficiency, and improved patient outcome in the fast growing $7.5B market. CorPath^TM is a Class II system that delivers and controls cath lab devices during interventional catheterization procedures.

POSITION SUMMARY:

To act as a lead technical and system knowledgeable resource in all matters related to the quality and reliability of company product. To lead and participate in a hands-on manner regarding all activities involved in the planning, problem resolution continuous improvement and conformance verification of the design, procurement, manufacture, distribution and customer service of company supplied goods and services

The ideal candidate will have extensive knowledge of medical devices in Quality systems and the accompanying design controls and is required. An understanding of software in motor controls and validation is a big plus. This position will interact with all functions in the company and its suppliers and design consultants. This is an ideal opportunity to join the team and make a real difference by using your experience and knowledge to shape the company’s products.

RESPONSIBILITIES:

1. Participate in the installation of the Quality System

2. Review and approve all documentation for accuracy and conformance to the QA system requirements.

3. Write inspection/test/calibration procedures for equipment and product

4. Perform failure analysis

5. Manage the completion of validation protocols and test plans

6. Participate in process and device validation and qualification including software.

7. Manage the inspection and MRB process and disposition of material

8. Perform Internal and Supplier audits and follow-up

9. Propose, initiate and follow-up corrective actions

REQUIREMENTS:

1. 6-12 years experience as an engineer in a directly related/regulated manufacturing environment (GMP/ISO 13485, military, etc.)

2. BS in an engineering discipline

3. Direct experience in one or more of the following: electro/mechanical devices, motion control electronics, Quality system implementation, injection molding, sterilization, safety testing, design validation and verification.

4. Excellent PC and communication skills

COMPENSATION:

A very competitive package including salary, bonus, and stock options to be scaled with respect to experience level.