bb7 is looking for a Systems Engineer with expertise in the development of medical devices, specifically injectables and infusion pumps, to work with our client, a global-leader in outsourced design, development, and technology-driven manufacturing. This position is based in Hudson, WI (close proximity to Minneapolis/St. Paul, MN).
- Provide technical guidance to a cross-functional development team by utilizing tools in the Design Development Process, Quality Management System, and information in other relevant standards to identify product requirements and develop appropriate test plans to challenge the product. Work closely with the test and quality group to trace product needs, design input requirements, and design outputs.
- Work with the design and manufacturing group to create appropriate design variants understand the impact of feature/size variation and performance.
- Support program and/or project management by assisting with the creation of scope, cost, and duration estimates for various tasks, and tracking and reporting time for various tasks.
- Support product compliance by working with the Quality Team. This includes knowing and understanding personal role in compliance to ISO 13485 with design controls, ISO 14971 risk management, IEC 62366, IEC 60601, and ITAR as required.
- Facilitate communication between team members, customer and flow through production facilities, including some day travel to customers and other company facilities as required.
- Bachelor of Science in Mechanical, Electrical, or Systems Engineering required
- Minimum of 10-15 years of product development experience with a focus on system integration of drug/biologic delivery devices
- Experience in medical device, combination products, or disposable diagnostics preferred
- Competent in ISO 13485 Design Controls, ISO 14971, and IEC 62366
- Strong analytical ability to guide complex design teams
- Competent in test protocol development and design verification
- Strong organizational, written, verbal, and interpersonal communication skills
bb7 and its Clients are equal opportunity employers and do not discriminate in employment on the basis of race, color, religion, sex, national origin, political affiliation, sexual orientation, veteran status, marital status, disability, age, membership in an employee organization, or any other classification protected by federal, state, or local law. We participate in E-Verify.