Sr. Design Assurance Engineer
Develop and implement Quality and Design initiatives to enhance product safety and quality in all stages of product and process development and ensure compliance to design specifications, QSR, and FDA requirements. Develops, establishes and maintains design assurance methodologies, systems, and practices which meet CSI, customer, and regulatory requirements. Provides focused design assurance engineering support within new product development and sustaining engineering to ensure the delivery of the highest quality product to the customer.
Essential Duties and Responsibilities:
- Works within a development team to identify and implement effective risk management controls to support the development, qualification, and commercialization of products to meet or exceed internal and external requirements.
- Support the testing and validation of new product designs.
- Responsible for executing biocompatibility testing and Usability/Human Factors evaluation
- Effective leader or team member in supporting quality disciplines, decisions, and practices.
- Applies sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues.
- Assures the development and execution of streamlined business systems which effectively identify and resolve quality issues.
- Develop and establish effective quality control and associated risk management plans. Ensure clarity and consistency in acceptance criteria and ensure the verification processes that are used are capable.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Six Sigma, SPC, DOE).
- Communicate verbally/written pertinent information to management.
- Additional duties as assigned or apparent.
Knowledge, Skills and Abilities Required for Successful Job Performance:
- BS. in Engineering or Related Technical Field.
- Minimum of 5 years design assurance experience preferably in QSR or ISO regulated environment.
- Prior medical device industry experience
- Knowledge of industry practices and standards in a highly regulated work environment
- General knowledge and application of technical and business concepts, procedures, and practices
- Ability to execute on specific deliverables such as product design verifications/validation, failure analysis.
- Problem solver with the knowledge of problem solving tools, capable of facilitating problem solving process. Collaborates effectively in a team environment.
- Able to influence decisions of others.
- Ventricular Assist Device (VAD) experience is preferred, but not required
- Knowledge of and effective application of engineering tools (e.g., DOE, SPC, Process Validation) expected along with a practical and partnering approach to Quality
- Experience leading cross functional teams in achieving goals that are established by the company.
- Computer and analysis tools experience required
CSI is an EEO/AA company: Women, Minorities, the Disabled and Veterans are encouraged to apply. If you are a job seeker with a disability and require accessibility assistance or reasonable accommodation to apply for an open position, please contact the Recruiting Department at Cardiovascular Systems, Inc., 1225 Old Hwy 8, New Brighton MN 55112, or call (651) 259-1600.