Principal Design Assurance Engineer
Location: Eden Prairie, MN
CHF Solutions is an early stage company focused on commercializing the Aquadex FlexFlow system. Our objective is to improve the quality of life for patients with heart failure and related conditions, such as fluid overload.
We are seeking Principal Design Assurance Engineer for our Eden Prairie, MN location.
This position partners with Marketing, Clinical, Regulatory, R&D and Operations and has the responsibility to provide Quality representation on teams facilitating front-end design, design transfer to manufacturing, and process/product improvements. This position is responsible for product safety and quality in all stages of product and process development and ensuring compliance to design specifications, ISO, FDA, and all applicable regulatory requirements. This position is also responsible for overall quality system procedures associated with design quality and complying with all CHFS and regulatory requirements.
- Provide effective quality engineering support in all aspects of the design and development phases in accordance with all applicable procedures, regulations and standards.
- Review, initiate, and/or approve change requests associated with: design verification & validation, risk management, usability, biocompatibility, shelf life, test method validations, equipment qualifications, sterilization, packaging, and labeling.
- Manage product development processes and procedures.
- Manage design history file organization, deliverables, maintenance and associated procedures.
- Manage the risk management process in accordance with ISO 14971, including risk management plans, hazard analyses, FMEAs, and risk management reports, throughout all product development phases.
- Partner with other functional areas, primarily R&D, in areas such as preparing test plans, data analysis, specifications, risk analysis, and change implementation.
- Capacity to interpret and contribute to electro-mechanical systems (electronics, pneumatics) and software design and testing.
- Ensure clarity and consistency in acceptance criteria and ensure the verification processes that are used are capable and statistically relevant.
- Facilitate marketing, product, and design specification creation with marketing and R&D for the finished device, sub-assemblies and components.
- Use statistical tools to analyze data, make acceptance decisions, and improve process capability (Gage R & R, TMV, SPC, DOE).
- Partner with engineering in test method development and validation.
- Identify, apply, and update engineering, technical, and regulatory standard requirements for medical devices.
- Work with design engineering, marketing and manufacturing management to establish, implement and maintain quality/manufacturing procedures
- Initiate CAPAs and lead or participate in CAPA team’s root cause analysis, action planning, and implementation.
- Supports methods/procedures for auditing, evaluating and approving suppliers of finished product and new materials/components.
- Conducts supplier audits as needed.
- Performs other related duties as assigned.
- B.S. or M.S. in Engineering or equivalent discipline
- Minimum of 10 years of experience preferably in FDA or ISO regulated environment
- Minimum of 5 years of experience in the medical device industry in a product development / design / design quality role
- Experience with software design, verification, and validation
- Experience in biocompatibility, human factors, electrical safety, hardware, and sterilization industry standards
- Proficient in driving risk management activities
- Experience in application of statistical methods to design reliability and process capability
- Working knowledge of statistical analysis/software experience preferred
- Effective verbal and written communication, analytical, and interpersonal skills
- Able to independently provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, and practicable, and consistent with organizational objectives.
- Able to work or lead cross-functionally and contribute as an effective team player
- Must be able to handle multiple tasks/projects and manage priorities accordingly
- Practical approach to quality and a partnering style with colleagues in all functions of the business
- Optimistic approach to challenges – “can do” style
- ASQ CQE preferred
How to Apply: If you are interested in applying for this position, email your cover letter and resume to firstname.lastname@example.org. Please indicate the position that you are applying for and the Requisition ID.
Requisition ID: 18-034
CHF Solutions, Inc. is an equal opportunity employer.