Principal R&D/Product Development Engineer

Surmodics, Inc.; Eden Prairie (MN); On-site; USD 112,000 - 169,000; Full time

Job summary

An established industry player is seeking a Principal R&D/Product Development Engineer to spearhead innovative medical device projects. This role involves leading cross-functional teams from concept through commercialization, ensuring compliance with quality standards, and translating user needs into validated products. The ideal candidate will possess strong analytical skills, a background in engineering, and experience in product development. Join a forward-thinking company dedicated to enhancing healthcare solutions and making a meaningful impact on patient care.

Benefits

401(k) with employer match

Tuition reimbursement

Student debt repayment program

Bonus program

Qualifications

• 7 years related work experience in product development.
• Ability to apply analytical skills to problem solving.
• Familiarity with statistical techniques and lab practices.

Responsibilities

• Lead product development activities from concept to commercialization.
• Manage multiple projects while ensuring on-schedule completion.
• Interface with medical personnel and contribute to product improvements.

Skills

Analytical Skills

Communication Skills

Interpersonal Skills

Problem Solving

Statistical Techniques

Education

Bachelor's degree in engineering

Tools

Solidworks

Lab Equipment

Job description

Principal R&D/Product Development Engineer

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Principal R&D/Product Development Engineer

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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 Principal R&D/Product Development Engineer will lead product development activities from concept to commercialization.

Principal 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
  

Minimum Qualifications

• Bachelor’s degree in engineering or related technical field.
• 7 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.
  
  

Surmodics determines base pay by evaluating market data, internal equity, skills, abilities and level of experiences for each unique, potential employee.

Surmodics offers a competitive compensation and benefits package, including a bonus program, 401(k) with employer match, tuition reimbursement and student debt repayment program.

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.

Targeted Salary Range

$112,500—$168,600 USD

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Education and Training

• Industries

  Medical Equipment Manufacturing

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