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SYNCARDIA SYSTEMS, LLC STRICTLY PRIVATE Admin-108 Rev 006 1

Job Title: Project Manager

I. General Information

Reports to: refer to SynCardia Organizational Chart, Quality-054

Supervises: refer to Quality-054

Exempt/Nonexempt: Exempt

II. Essential Duties and Responsibilities

The Project Manager will actively facilitate business growth by enabling the quickest time to market

for approval of new products and existing product line extensions. This includes responsibility for

product planning and execution throughout the driver and pump product lifecycle, including: gathering

and prioritizing product and customer requirements, defining product vision, and working closely with

engineering disciplines, sales, marketing and clinical support to ensure revenue and customer

satisfaction goals are met.

The Project Manager will work with cross-functional teams to ensure that design elements (Design

Planning, Design Inputs, Design Outputs, Design Verification, Design Validation, Design Transfer,

Design Changes, Design Reviews and Product Obsolescence) are properly scoped and met for each

development project. This includes responsibility for planning, requirement, specification,

verification, validation and risk management documents. The individual will work with the cross-

functional team to assure product designs provide necessary safety, efficacy, regulatory compliance

and customer satisfaction while balancing the need for speed to market as well as cost effectiveness.

Lead cross-functional teams in achieving new product introductions from project proposal approval

to commercialization.

Develop detailed work elements, project tasks, critical milestones and contingency plans to meet

design control requirements and speed to market.

Prepare Design History File documents and ensure appropriate design review is conducted. Facilitate

the SynCardia Design Control Process ensuring that all phases are successfully accomplished.

Function as design verification lead on assigned project teams with accountability for the

development, execution, and reporting of verification activities.

Spend time in the field, with customers and users, to gain more knowledge of product application and

customer needs.

Report to management on the schedule and status of the project.

Works on problems of complex scope where analysis of situation or data requires review of defined

factors.

Coordinates assigned project resources (technicians, equipment, external test labs) with the objective

of ensuring data integrity and maximizing test throughput efficiency.

Creates and executes comprehensive design verification test plans including sample sizes for assigned

projects.

Applies basic engineering statistics to help the project team in making fact-based decisions (D.O.E.,

hypothesis testing, etc.)

Analyzes data from verification and reliability tests for conformance to pre-determined acceptance

criteria and prepare formal reports and results summaries.

Assists engineering team with root cause analysis for problems identified during verification and

validation testing.

SYNCARDIA SYSTEMS, LLC STRICTLY PRIVATE Admin-108 Rev 006 2

III. Responsibility and Authority Affecting Quality

Initiate action to prevent the occurrence or potential occurrence of any nonconformities relating to the

product, process and Quality System.

Identify and record any problems relating to the product, process and quality system.

Initiate, recommend or provide solutions through designated channels.

Verify the implementation of solutions.

IV. Position Requirements

A. Skills and abilities (required for job)

Experience in development of new medical devices.

Proficient technical writing skills; able to effectively and concisely communicate issues and technical

information.

High level of technical competence in data analysis and product related calculations. Must be able to

maintain a high degree of accuracy and analytical thinking.

Strong problem solving and decision-making skills.

Knowledge of applicable regulatory standards and requirements for medical device development.

Working knowledge of relationships between regulations, labeling, process and product. Knowledge

of quality management systems.

Ability to work independently and/or function with minimal supervision.

B. Education, experience and training (required for the job)

Bachelors Degree in Engineering, Engineering Sciences or Business Administration.

Minimum 5 years working experience in a regulated environment - Food and Drug Administration

(FDA), or International Organization for Standardization (ISO) registered experience preferred.

Previous experience in design control activities specific to implantable Class III medical devices

preferred.

Proficient at computer workstation use and applications.

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