Senior R&D Engineer

10 hours ago


Saint Paul, Minnesota, United States Biomerics Full time
Job Title: Senior R&D Engineer

Biomerics is seeking a highly skilled Senior R&D Engineer to join our team. As a key member of our engineering team, you will be responsible for designing and developing guidewires from concept to production that exceed customer expectations.

Key Responsibilities:
  • Lead design, development, validation activities through product life cycle for development products in accordance with project scope.
  • Execute deliverables for Design Control process to deliver the desired product to production in a cost-effective manner while hitting product performance and profitability goals.
  • 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 (MDR, ISO, EN, etc.) of varying project types.
  • Develop customer specification/requirements to translate into clear, concise performance and functional requirements with an upfront design for manufacturing mindset.
  • Develop strategy for robust design, process, and testing criteria to satisfy requirements.
  • Assess, anticipate, and mitigate risks.
  • Optimally select risk assessment tools throughout the product development lifecycle.
  • Lead and motivate development engineers/technicians/operators to perform hands-on prototyping, testing, and process development.
  • Design advanced tooling/fixturing in a cost-effective manner.
  • Discover, evaluate, and implement new technologies and ideas for new products.
  • Identify and use statistical tools to analyze data, make development decisions, and improve process capability (Six Sigma, SPC, DOE).
  • Develop, review, and refine manufacturing procedures and test/inspection plans to ensure quality requirements are met and manufacturing process risks are mitigated with emphasis on design for manufacturing.
Requirements:
  • 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.
  • In-depth knowledge of design controls, process development, and characterization of Test Methods for selection, verification, and validation of components, sub-systems, and assemblies.
  • Efficient in 3D modeling (SolidWorks preferred) and working knowledge of drafting specifications such as GD&T.
  • Experience in a regulated environment and demonstrated competence in required documentation and industry-accepted practices such as Good Manufacturing Practices (GMP), ISO 13485 Design Control, and Quality Systems Regulation (QSR).
  • 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).
  • Excellent technical writing skills.
  • Strong internal and external communication, presentation, follow-through, and organizational skills.
  • Proven ability to work effectively with coworkers at all levels of the organization.
  • Demonstrated ability to lead team activities.
  • Management, coaching, or mentoring experience a plus.


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