R&D Engineer 2

Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease.

The R&D Engineer 2 will provide engineering support for catheter-based medical device design and development. The primary focus of this position is to provide additional R&D engineering support for the design, development, testing, and analysis of medical devices. This includes developing, optimizing, and validating process and test methods for building medical devices, developing solutions for routine technical problems, and collecting and analyzing data.

Technical Support/Leadership (80%)

• Execute testing protocols throughout Design Verification, Design Validation, and Process Validation activities.
• Source and coordinate outside test services, as required.
• Train operators and/or peers on test methods and equipment
• Manage readiness of testing resources, including equipment calibration/PM, fixture suitability, and inventory of test consumables (e.g. test media, guidewires, valves/connectors, etc..)
• Participate on cross-functional development teams that manage projects from concept through commercialization.
• Assist in conceptualization, design and development of new devices and design changes
• Fabricate device prototype components and assemblies for early feasibility concept as well as fabrication of Design Characterization and Design Verification components and assemblies.  
• Assist in the development of robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.
• Assist in the validation and qualification of test methods to ensure method validity and appropriateness.
• Document device fabrication (traceability), test results, and analysis (as applicable) in line with cGDP
• Applies knowledge and skills to successfully address and resolve technical problems and challenges.
• Generate purchase orders, coordinate orders and deliveries with vendors, manage test equipment inventory and calibration, manage shipping/receiving R&D materials as necessary.
• Operate with minimal supervision, deliver results in a timely manner.

Communication (20%)

• Participate in product development teams and provide status of assigned tasks.
• Author protocols and reports including engineering studies using basic statistical methods.
• Communicate with outside suppliers as needed.
• Communicate ideas effectively in a cross functional group. Present test results to peers, project leaders, and/or management.
• Proactive identification of issues or circumstances that may adversely affect projects

• Bachelor’s Degree in Engineering or related technical field and 3 + years related technical experience preferably in catheter development OR 5+ years related technical experience
• Ability to apply analytical skills and scientific technical principles in problem solving and development
• Demonstrated software skills including: Solidworks, Microsoft Office, Minitab, database, and other applicable software programs.
• Catheter-based knowledge including extrusion, braiding, reflow, molding, adhesives, and polymer experience desired.
• Good written and verbal communication skills
• Experience working in a laboratory with knowledge of GMP and GLP, and an ability to operate lab equipment with practical and technical knowledge of common lab instrumentation and equipment.
• Ability to design (fixture, equipment, and testing). Has working knowledge of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. Solidworks).
• Strong interpersonal and organizational skills and the ability to work effectively as a team member.
• Working knowledge of United States and international standards as applicable to the department

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, employee stock purchase plan and stock options.

Surmodics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or veteran status.