Engineering Manager, Product Development
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 an Engineering Manager, Product Development for our Eden Prairie, MN location.
This position is responsible for executing development programs of various complexities for medical devices utilized in aquapheresis therapy. These devices include electro-mechanical systems and related disposable mechanical products and accessories. The individual in this role will be involved with developing new products, enhancing existing products, and implementing compliance improvements. This position partners with Marketing, Quality, Regulatory, Clinical, and Operations. This is a working manager role and combines personnel and project management responsibilities that are critical to the success of CHF Solutions’ business strategy.
- Direct activities of a diverse product development engineering team.
- Provide management, coaching, and development opportunities to a direct staff of 4-8 engineers.
- Lead internal cross-functional teams, external suppliers, and service providers to complete development projects on time with desired outcomes.
- Execute tasks of various complexities throughout all development phases and in accordance with all applicable procedures, regulations, and ISO standards.
- Evaluate product qualification activities and risk management documentation against released standards and best practices. Find and close gaps as appropriate.
- Generate new product development concepts and prototypes for existing product enhancements, as well as new product designs.
- Develop and execute product verification and validation activities.
- 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.
- Partner with other functional areas in preparing test plans, data analysis, specifications, risk analysis, and change implementation.
- Capacity to interpret and contribute to electro-mechanical systems and related disposables.
- Lead challenging team discussions resulting in robust decisions, with respect to product development plans.
- Facilitate effective communications with project team, support team, and management.
- Manage project execution to achieve project plan/contract. Proactively address issues to minimize their impact to project.
- Participate in project updates with management in a professional and unbiased manner.
- Effectively engage with external suppliers, as required by the project.
- Expect travel to range from 0-10% depending upon the individual project.
QUALIFICATIONS & COMPETENCIES
- Degree in Mechanical, Electrical, Biomedical Engineering, or equivalent.
- 8+ years of experience with a Bachelor’s degree, or 5+ years of experience with a Master’s degree.
- Preferred experience in the medical device industry with a variety of devices including capital equipment, software, hardware, disposables and/or catheters.
- Experience in biocompatibility, human factors, electrical safety, hardware, and sterilization industry standards is a plus.
- Demonstrated track record of leading complex development programs and initiatives.
- Excellent written and verbal communication skills.
- Ability to influence others.
- Strong analytical and problem-solving skills.
- Demonstrated decision making skills.
- Good interpersonal skills.
- Must be able to handle multiple tasks/projects and manage priorities accordingly.
- ‘Can-do’ attitude is required.
- Ability to manage through ambiguity
How to Apply: If you are interested in applying for this position, email your cover letter and resume to email@example.com. Please indicate the position that you are applying for and the Requisition ID.
Requisition ID: 19-053
CHF Solutions, Inc. is an Equal Opportunity Employer – Minorities/Females/Veterans/Disabled