Job DescriptionPosition Summary The Engineer III, Product Design position in the Vascular Access Product Engineering team will play a critical role in driving the design, development, and implementation of medical devices. This role involves collaborating closely with cross-functional teams including marketing, commercial, quality, regulatory, and medical groups-to ensure that all product designs meet regulatory standards and customer expectations.
As a subject matter expert (SME) in medical device development, this position will drive key projects of significant complexity while applying sound engineering principles, experimental methods, and analytical techniques. The ideal candidate will bring extensive hands-on experience in medical device design and development, with a strong background in documentation, testing, and risk management.
Essential Duties & Responsibilities- Drive Design Control Activities: Work on all aspects of design control, including Requirements Management, Design Outputs, Verification & Validation (V&V), Design History File (DHF), and Risk File management.
- Drive Product Development: Plan, design, and implement new products and changes to post market products, ensuring compliance with applicable medical device standards.
- Solve Complex Engineering Challenges: Apply experimental, computational, and analytical methods to address technical challenges and ensure product performance.
- Develop and Maintain Technical Documentation: Create and maintain product specifications, requirements, architecture, design, and usability documents.
- Conduct and Oversee Testing: Design and execute exploratory, bench, and V&V testing, developing test protocols and generating comprehensive reports.
- Collaborate with Cross-Functional Teams: Partner with marketing, quality, and regulatory teams to ensure design requirements align with business objectives and regulatory compliance.
- Corrective Actions and Preventable Actions: Assist manufacturing operations and quality with the root cause analysis, and the development and implementation of solutions for non-conforming events.
- Design & Model Devices: Utilize SolidWorks to create and refine device models for various product lines, with a focus on high-volume disposable medical devices.
- Partner with Suppliers & Customers: Collaborate with customers and suppliers to refine designs and ensure manufacturability, with an emphasis on plastics/polymer engineering and injection molding.
Knowledge & Skills- Proven Expertise in Medical Device Design: Extensive hands-on experience developing and improving medical devices, including knowledge of FDA regulations and ISO standards.
- Proficiency in SolidWorks: Strong capability in 3D modeling and drafting and the design for manufacturability.
- Material & Manufacturing Knowledge: Deep understanding of medical-grade plastics, injection molding principles, and common joining methods.
- Analytical & Problem-Solving Skills: Strong ability to apply statistical methods, including Design of Experiments (DOE) and tolerance analysis, to solve complex engineering problems.
- Strong Communication & Collaboration Skills: Ability to effectively communicate with technical and non-technical stakeholders across departments and with suppliers.
- Knowledge of Engineering Mechanics & Physics: Solid understanding of the principles underlying mechanical design.
- Familiarity with Machine Shop Practices: Understanding of basic machining operations.
- Time Management: Ability to handle multiple priorities and meet key deadlines under pressure through effective time management skills.
Minimum Qualifications, Education & Experience - Bachelor of Science (B.S.) degree in Mechanical Engineering or a related field from an accredited institution.
- Minimum of 4 years of relevant experience in medical device design and development.
- Must be at least 18 years of age.
Work Environment- Primarily operates in a professional office environment with standard office equipment.
- This role is largely sedentary but may involve occasional visits to labs or manufacturing facilities.
- Typically requires travel less than 5% of the time.
