- Department Name: Engineering
- Reports to: Director of Program Management
- Supervises: Program Managers
- Exempt/Nonexempt: Exempt
Essential Duties and Responsibilities
The Engineering Program 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 Engineering Program 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.
- The Engineering Program Manager will:
- 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
- The Engineering Program Manager:
- Works on problems of complex scope where analysis of situation or data requires review of defined factors
- Co-ordinates assigned project resources (technicians, equipment, external test labs) with the objective of ensuring data integrity and maximizing test throughput efficiency
- Lead a team that is charged with the TAH-t and Driver product line development and evolution.
- 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
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.
- Skills and abilities (required for the 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.
- Education, experience and training (required for the job)
- Bachelor’s Degree in Engineering, Engineering Sciences or Business Administration.
- Minimum 2 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.
- Working environment
- Work Station Area: Office.
- Special Factors in the Work Area: None
- The working environment is indoors and is seasonally heated and cooled with minimal noise levels.
- The position requires considerable sitting, typing and the ability to move objects of less than 25 pounds.
- The position requires the ability to communicate in person, telephonically and via email.
Interested in applying for this position? Please send your cover letter and resume to email@example.com.