Our Plymouth, MN has an opening for a Senior Design Engineer to join their growing team. If you're looking to join a growing organization and work with new customers and design new products this could be your next career opportunity . The Senior Design Engineer will be responsible for translating business needs into technical solutions across a variety of vascular device platforms. The engineering role performs assignments involving considerable responsibility including: design of medical devices and sub-assemblies, development of product specifications, analysis of engineering problems and demonstration of design compliance through verification and validation activities. The role requires close collaboration with Customers, Marketing, Management, Engineering, Regulatory, Design Assurance, and Operations, throughout the development cycle.
Accountabilities and Responsibilities:
- Adheres to Integer's values and all safety, environmental, security and quality requirements including, but not limited to: Quality Management Systems (QMS), Safety, Environmental and Security Management Systems, U.S. Food and Drug Administration (FDA) regulations, company policies and operating procedures, and other regulatory requirements.
- Utilizes customer requirements to design innovative medical devices for vascular projects. Assignments may begin as initial concepts based on user needs and evolve into 'hands-on' prototyping to gain clinical design feedback.
- Accountable for verification and validation testing to demonstrate product compliance.
- The use of FMEA, tolerance analysis, design for manufacturability (DFM) and other methods to mitigate risk will be essential throughout the design process.
- Provides planning inputs and executes on project deliverables to meet established metrics.
- Utilizes design tools as required to optimize critical aspects of the design when required.
- Develops and documents test methods to evaluate product performance.
- Authors technical documents including but not limited to: technical memorandums, design verifications/validations, intellectual property applications, input/output matrices, and product specifications.
- Prepares detailed engineering drawings or component specifications to define the product design.
- Reviews product designs/drawings for compliance with applicable medical device standards, company requirements, customer contract requirements, and any other related standards.
- Generates, reviews and approves engineering change orders.
- Investigates root cause for product and process failures and establishes corrective actions.
- May supervise and mentor lower level engineers, technicians, and operators.
- Develops new and unique approaches to complex problems and advanced technology beyond previous company involvement.
- Works in an office, lab and clean room environment.
- Performs other duties as required.
Education & Experience:
- Minimum Education: Bachelor's degree in related field.
- Minimum Experience: 7+ years' experience.
Knowledge & Skills:
- Experience with design controls, FDA/ISO regulations.
- Knowledge in catheter design, manufacturing and test
- Depth of knowledge in manufacturing technologies, e.g. molding, extrusion, thermoforming, adhesive bonding, split die forming, hot air reflow, braiding, laser and resistance welding, soldering, wire forming, electropolishing, sterilization, etc.
- Proficiency with mechanical CAD (SOLIDWORKS preferred).
- Demonstrated problem solving skills. Proficiency with root cause and statistical analysis tools.
- Well organized with strong verbal, written and interpersonal communication skills for effectively interfacing with internal and external customers.
- Demonstrated ability to lead team activities and act as a coach.
- Knowledge of cardiovascular anatomy and electrophysiology a plus.