Engineer 2, R&D

Ready to make a difference by utilizing your talents? Join a team driven by a mission to help patients, and a culture focused on developing medical device and diagnostic solutions.

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 Engineer 2, within our R&D team, will execute technical design for catheter-based medical device design and development. The primary focus of this position is to collaborate with R&D engineering on the design, development, testing and analyzing of medical devices. This would include developing, optimizing, and validating processes for building a medical device, developing solutions for routine technical problems, and collecting and analyzing data. 

Responsibilities 

Laboratory and Production (40%)

•    Fabricate device prototype components and assemblies for early feasibility concepts which may include Characterization and design freeze prototypes
•    Contribute to the design and development of new catheter-based products or line extensions
•    Perform tests for design freeze by following written or verbal instructions; collect data and record test results; analyze test data, and present results to peers and management when necessary. 
•    Design, procure and fabricate simple tooling and fixturing
•    Assist in the execution of test protocols and test equipment
•    Assist with verification and validation activities through regulatory clearance and design transfer
•    Support implementation of Engineering work orders for DV, IOQ’s or PVALS. 
•    Develop and maintain a working knowledge of laboratory equipment

Technical Leadership (40%)

•    Refine processes and test methods in the development of new products while working with the engineering team
•    Develop mechanical test methods and associated documentation
•    Assist with developing and troubleshooting new equipment including fixture design and equipment qualifications
•    Source component materials and equipment as needed
•    Train peers or operators 
•    Communicate ideas effectively in a cross functional group. Ability to present test results to peers, lead engineer and/or management. Notifies manager upon recognition of factors that may affect project.
•    Generate purchase orders, coordinate orders and deliveries with vendors, R&D stock checking including monitoring material and test inventory & shipping materials/receiving materials 

Communication (20%)

•    Participate in development teams and provide status of assigned tasks
•    Communicate with outside suppliers as needed

Minimum Qualifications

•    Bachelor’s degree in Mechanical or Technical Engineering or equivalent.
•    Experience: Minimum 5 years of experience in R&D or process development preferably in regulated FDA/QSR and ISO environment. 
•    Catheter-based knowledge including extrusion, braiding, reflow, molding, adhesives, and polymer experience desired
•    Ability to work independently
•    Successfully manage multiple tasks on an on-going basis
•    Strong communication skills
•    Solid Words competence desired
•    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.
•    Proficiency in computer skills (MS Windows, MS Outlook, Word, Visio, Excel and PowerPoint) and ability to enter data in Microsoft Project and / or Minitab for data analysis.
•    Ability to analyze and evaluate data and recommend actions; has practical and technical knowledge of root cause and statistical methods and analysis. Exposure to statistical analysis and experimental design helpful.
•    Ability to design (fixture, equipment, and testing). Has general technical awareness of rapid prototyping techniques and an ability to read and understand CAD drawings (e.g. SolidWorks).
•    Interpret and understand geometric tolerances.

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.

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