Senior R&D Sustaining Engineer

Surmodics Eden Prairie , MN 55344

Posted 2 months ago

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 Senior R&D Sustaining Engineer will be responsible for the design and development aspects, including design and/or process alterations, of an existing product. They will participate on cross-functional project teams in the post-manufacturing transfer/post-commercialization phases of the product lifecycle. Additionally, they will support the team with planning and executing of technical projects, or portions of a project, for products in commercial use.

Responsibilities

Technical Leadership (40%)

  • Provide engineering support to the Design / Development Engineering, Marketing, and Operations departments as required.

  • Develop or interpret design inputs and outputs to evaluate manufacturing changes to existing product or newly distributed product.

  • Implement design changes to improve the quality of existing products and/or the customer experience.

  • Support risk management activities and risk management reviews on existing products.

  • Provide R&D support for non-conformance investigations regarding component failures, finished goods failures, and product returns.

  • Provide R&D support for customer complaints, including product/record investigation, health risk assessments, identification of CAPAs, and report generations.

  • Contribute to design/development of product line extensions and product improvements.

  • Resolve technical problems and support completion of team deliverables.

  • Develop realistic actions, timetables, and resource estimates for technical projects.

  • Working knowledge of United States and international standards as applicable to the department.

Communication (20%)

  • Coordinate design change and process change activities.

  • Communicate project plans and status cross-functionally to facilitate the product development process.

  • Author protocols and reports including engineering studies using basic statistical methods.

  • Communicate with outside suppliers as needed.

Laboratory and Production (40%)

  • Provide R&D support with verification, qualification, and validation activities on existing products.

  • Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements

  • Manage test protocols, testing, and reporting.

  • Support maintenance of lab equipment and materials needed for testing.

  • Design, assemble and evaluate rapid prototype models in order to assess technical feasibility of various solutions.

Minimum Qualifications

  • Bachelor's Degree in Engineering or related technical field or 5 + years' work-related experience.

  • Familiarity with various materials and processes for cardiovascular catheter production.

  • Ability to apply analytical skills and scientific technical principles in problem solving and development.

  • Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, Minitab, and other applicable software programs.

  • Strong interpersonal and organizational skills and the ability to work effectively as a team member or leader.

  • Ability to manage multiple projects and timelines.

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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Senior R&D Sustaining Engineer

Surmodics