Staff Manufacturing Engineer (NPI)

Resonetics

  • Hutchinson, MN
  • Permanent
  • Full-time
  • 1 month ago
Overview:Resonetics is a global leader in advanced engineering, prototyping, product development, and micro manufacturing, driving innovation in the medical device industry. With rapid expansion across all our locations, we continue to push the boundaries of technology while fostering a dynamic, employee-centered culture. Our commitment to excellence and continuous improvement makes Resonetics an exciting place for professionals passionate about shaping the future of micro-manufacturing and being part of something bigger.The Staff Manufacturing Engineer accomplishes goals by facilitating, organizing, and managing resources and initiatives to support business activities. This position will be responsible for managing the production development and readiness activities for finished medical devices and catheter sub-assemblies. This individual will act as a NPI core team member, representing the interests of manufacturing engineering and operations. The product focus of will be on Class 2 and 3 medical device assemblies in the interventional space covering a range of therapies and technologies. This individual will manage process development and continuous improvement projects while transferring new products and processes from our multi-site Agile & LightSpeed Lab teams.Join Resonetics and be part of a team that’s redefining medical device manufacturing. If you’re passionate about innovation and thrive in a fast-paced environment, we’d love to hear from you. Responsibilities:
  • Under limited supervision identifies, plans, and leads execution of project & manufacturing support initiatives to solve complex problems. Concurrently leads multiple initiatives in development, ongoing manufacturing, and in support of business unit goals. Prioritizes, leverages team to remove constraints and deliver results.
  • Advanced understanding and application of broader technical principles, theories, and concepts within engineering discipline.
  • Guides the successful completion of projects and/or process design and improvements that will enable technical business unit area to meet goals; likely to support cross-business unit/ global initiatives.
  • May be considered internal business unit subject matter expert; proactively serves as a technical resource for developing engineers and technicians.
  • Scopes, Plans and leads development, qualification, and improvement activities for new and existing manufacturing processes, equipment and test methods. Scopes, plans and leads completion of requisite supporting documentation, ensuring compliance with industry standards and Quality System requirements.
  • Proactively leads issue investigation and Develops solutions to complex high impact problems; applies broad expertise and knowledge in specialized fields.
  • Exercises considerable latitude in determining technical objectives of projects; provides solutions to issues and inefficiencies in an effective way; understands the interrelationships of different disciplines/business units and financial impact to the business.
  • Begins to maneuver through ambiguity with ease; inspires steadfastness in the face of significant business unit pressures.
  • Recognizes the need for change, making informed decisions and assessing multi-faceted calculated risks, compliantly enabling solutions for business unit area success.
  • Perceived as an innovative resource for respective team and/or business unit.
  • Develops networks that are diverse in level and business unit expertise; identifies and initiates new relationships to accomplish business objectives.
  • Interacts with technical business unit leaders and customers. Serves as respected technical resource for others within multi-business unit/global team initiatives with no assistance or guidance.
  • Formally mentors and provides career advice to junior engineers/ technicians within a work group/project team.
  • Solves complex problems and can identify viable and often innovative options that impact multiple business units.
  • Assure safety and regulatory compliance of systems by creating failure/safety reports when issues are identified.
Required Qualifications:
  • Typically requires minimum of 8 years of related experience with Bachelor’s degree in technical discipline; or 6 years with Master’s degree; or a PhD with 3 years’ experience; or equivalent experience.
  • Applies extensive expertise and has knowledge of best practices in respective engineering discipline and familiarity with the broader underlying concepts of related engineering and business disciplines. Demonstrated expertise in lean and six sigma concepts and tools.
  • Expertise with QSR and/or ISO 13485.
  • Deep expertise and broad application of lean and six sigma concepts and tools of Lean/CI Principles, Systems and common tools. Including: Line Balancing, Equipment Capacity modeling, 5S, 8 forms of waste, Value Stream Maps, Kaizen, WIP optimization, manufacturing cell-line-facility layout design & optimization, and data analysis.
  • Excellent written and verbal communication skills.
  • Excellent organizational, collaboration and presentation skills.
Preferred Qualifications:
  • MS in applicable Science or Engineering field.
  • Demonstrated experience interventional device design, assembly, packaging & sterilization.
  • Experience as a multi-discipline core team lead for a finished medical device.
  • Process Development & Validation Experience.
  • Certification or training in Lean Six Sigma methodology.
  • ISO 13485 (Medical Devices).
  • Quality Management Systems). Project Management Professional (PMP).
Compensation:The compensation for this role is competitive and will be based on experience and qualifications. The anticipated range is $105,000-135,000/annually

Resonetics