Medtronic - Boulder, CO

posted about 1 month ago

Full-time - Mid Level
Boulder, CO
Miscellaneous Manufacturing

About the position

As a Senior R&D Engineer in Advanced Manufacturing Engineering at Medtronic, you will play a crucial role in the design-centric product development process. This position focuses on new product development, utilizing advanced manufacturing engineering expertise to transition prototypes into scalable, manufacturable products. You will collaborate with cross-functional teams to create user-friendly solutions that positively impact clinicians and patients, while also ensuring compliance with regulatory standards and product specifications.

Responsibilities

  • Lead the development and maintenance of technical knowledge related to airway access devices and endoscopic devices.
  • Develop and implement advanced mechanical concept designs, performing tolerance analysis and finite element analysis.
  • Design components for manufacturing processes such as plastic injection molding and machining, considering high-volume assembly.
  • Ensure designs meet product specifications, regulatory requirements, and international standards.
  • Provide technical feasibility assessments and translate voice of customer (VOC) feedback into engineering design requirements.
  • Develop specifications, test methodologies, and test equipment to evaluate design concepts.
  • Perform calculations, analyses, and engineering testing to verify designs, documenting results in reports.
  • Create and release engineering drawings and process engineering change orders.
  • Collaborate with suppliers to ensure components meet design requirements and diagnose design problems.
  • Develop and optimize manufacturing processes for scalable production of high-quality medical devices.
  • Implement Design for Manufacturability (DFM) and Design for Assembly (DFA) principles to enhance product reliability.
  • Conduct process validation, including IQ, OQ, and PQ, to ensure compliance with regulatory standards.
  • Travel to vendor locations and customers to ensure program deadlines are met and troubleshoot issues.
  • Present technical findings and project status to cross-functional teams and management.
  • Recommend technology options for system, process, facility, or program improvements.
  • Support the transfer between phases of the project life cycle.

Requirements

  • Bachelor's degree in Mechanical Engineering, Biomedical Engineering, Design and Industrial Engineering, or a related technical field with 4+ years of engineering experience, or an advanced degree with 2+ years of engineering experience.

Nice-to-haves

  • Experience with 3D modeling software, preferably SolidWorks.
  • Proficiency in Geometric Dimensioning and Tolerance (GD&T) practices.
  • Strong understanding of mechanical engineering principles and methodologies.
  • Expertise in Design for Manufacturability (DFM) and Design for Assembly (DFA) principles.
  • Knowledge of process validation, including IQ, OQ, and PQ.
  • Experience with advanced manufacturing technologies and processes, such as additive manufacturing and robotics.
  • Familiarity with regulatory standards and quality systems in the medical device industry.
  • Experience with rapid prototyping methods.
  • Experience in the design and manufacture of medical devices.
  • Experience in product design and development in an R&D environment.

Benefits

  • Health insurance
  • 401k retirement plan
  • Paid holidays
  • Flexible scheduling
  • Professional development opportunities
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