Senior R&D Engineer

7 days ago


Brooklyn Park, Minnesota, United States Biomerics Full time
Senior R&D Engineer

Biomerics is seeking a highly skilled Senior R&D Engineer to play a key role in designing and developing guidewires from concept to production that meet customer expectations.

Key Responsibilities:
  • Product Development Leadership: Lead design, development, and validation activities through the product life cycle for development products in accordance with project scope.
  • Deliverables Execution: Execute deliverables for the Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and profitability goals.
  • Design History and Controls: Manage all Design History File(s), Design Controls, Design Verification & Validation, and all necessary activities in accordance with all internal and external processes, procedures, and standards.
  • Customer Requirements: Develop customer specification/requirements to translate into clear, concise performance and functional requirements with an upfront design for manufacturing mindset.
  • Design Strategy: Develop strategy for robust design, process, and testing criteria to satisfy requirements.
  • Team Leadership: Lead and motivate development engineers/technicians/operators to perform hands-on prototyping, testing, and process development.
  • Tooling and Fixturing: Design advanced tooling/fixturing in a cost-effective manner.
  • Technology Evaluation: Discover, evaluate, and implement new technologies and ideas for new products.
  • Manufacturing Procedures: Develop, review, and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated.
  • Engineering Support: Provide engineering support and leadership to establish, implement, and deliver products to production that meet project timeline, design, and profitability targets.
Requirements:
  • Education and Experience: Preferred bachelor's degree in engineering with 6-10 years of medical device experience or a combination of work history in the medical device or relevant field totaling 9-12 years.
  • Design Controls and Process Development: In-depth knowledge of design controls, process development, and characterization of Test Methods for selection, verification, and validation of components, sub-systems, and assemblies.
  • Technical Skills: Efficient in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications such as GD&T.
  • Regulated Environment: Experience in a regulated environment and demonstrated competence in required documentation and industry-accepted practices.
  • Problem-Solving Skills: Complex problem-solving skills (e.g., use of statistical techniques such as design of experiments (DOE), Analysis of Variance (ANOVA), t-tests, normality, and process capability metrics in decision making).
  • Technical Writing: Excellent technical writing skills.
  • Communication and Collaboration: Strong internal and external communication, presentation, follow-through, and organizational skills.
  • Teamwork: Proven ability to work effectively with coworkers at all levels of the organization.

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