Senior R&D/Product Development Engineer

About the position

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/Product Development Engineer will lead product development activities from concept to commercialization.

Responsibilities

• Lead conceptualization, design and development of new devices or elements of new devices with the intent of commercialization per Quality System Requirements
• Acts as leader and/or primary technical contributor for cross-functional development team(s) that manage projects from concept through commercialization.
• Accurately and efficiently translates user and patient needs into verified/validated devices, through creation and refinement of design requirements, design specifications, and test method, and procedures while adhering to design controls best practices.
• Develop robust test methods and design test fixtures to ensure that selected materials and prototype designs are accurately evaluated against the specification and requirements.
• Owns verification and validation activities through regulatory clearance and design transfer.
• Manage multiple projects and maintain on-schedule while serving as the primary point of contact for management for those projects.
• Drives design reviews and ensures on time completion of design control deliverables.
• Design, assemble and evaluate prototype device assemblies in order to assess technical feasibility of various solutions.
• May be responsible for direct reports, including reinforcing the open-door policy and ensuring duties, responsibilities, authority, and expectations for direct reports are defined and understood.
• Actively identifies systemic department and organizational improvements as well as product portfolio expansion opportunities; helping to refine our product development strategy and roadmap.
• Interface with physicians and other medical personnel in a professional manner (maintaining confidentiality and intellectual property vigilance.)
• Contribute to design/development of product line extensions and product improvements.
• Author protocols and reports including engineering studies using basic statistical methods.
• Communicate with outside suppliers for component sourcing and refinement.
• Develop and own true clinical expertise around clinical/market focus area including: entirety of disease condition, relevant anatomical and systemic knowledge, medical management, surgical, and interventional treatment options, relevant product & procedural treatment options, overall clinical risk vs. benefit assessment.

Requirements

• Bachelor's degree in engineering or related technical field.
• 5 years related work experience
• Ability to apply analytical skills and technical principles to problem solving and product development.
• Good written and verbal communication skills.
• Performs work with minimal supervision, in a timely manner.
• Strong interpersonal and organizational skills and the ability to work effectively as a team member.
• Familiarity with statistical techniques
• Demonstrated computer skills preferably Solidworks, spreadsheets, word processing, database, and other applicable software programs.
• Working knowledge of common lab equipment (caliper, micrometer, tensile tester, pressure tester, vision measurement system) and knowledge of lab practices and techniques).
• Working knowledge of United States and international standards as applicable to the department.

Benefits

• Competitive compensation and benefits package
• Bonus program
• 401(k) with employer match
• Tuition reimbursement
• Student debt repayment program