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Open Positions

Senior Manufacturing Engineer

The Senior Manufacturing Engineer will be responsible for managing the production development and readiness activities for finished medical devices and catheter sub-assemblies. This individual will be a new product introduction core team member representing the interests of manufacturing engineering and operations. The product focus will be on Class 2 and 3 medical devices in the interventional space covering a range of therapies and technologies. This individual will lead process development, provide design-for-manufacturability input, and lead continuous improvement projects as part of launching new products in partnership with Resonetics’ Agile & LightSpeed development teams.
  • Management of new and existing medical device programs. Responsibilities include maintaining development/ build schedules, customer technical interface, and working with Resonetics Business Development Managers and other Resonetics sites for coordinated production.
  • Design and develop manufacturing processes, tooling, and fixtures that result in sufficient capacity to meet customer demand while also promoting product quality, process efficiency, and operator safety.
  • Provide production line support including, but not limited to, implementing process improvements, troubleshooting equipment, training, and addressing operator inquiries.
  • Generate and modify manufacturing process documentation and assure that documentation follow established policies and procedures per Resonetics’ established Quality Management System.
  • Drive utilization of process improvement techniques to solve technical problems and make scale-appropriate equipment and process recommendations.
  • Prepare engineering reports and communicate results to both internal (corporate) & external parties (customer).
  • Drive process validation and documentation (IQ/OQ/PQ, TMV’s, Manufacturing Processes, Equipment Commissioning, Preventive Maintenance, etc.).
  • (BS) in a technical discipline; Manufacturing, Mechanical, or Bio-Medical. or relevant experience.
  • Minimum of 6 years’ experience in a regulated manufacturing environment preferrably focused on medical device manufacturing.
  • Designing and manufacturing products preferably class 2 or 3 finished medical devices. Other experience will be considered.
  • Proficient in new product introduction and PDP product development planning.
  • Demonstrated work ethic and understanding of deadline management.
  • Demonstrated experience solving advanced technical problems using good engineering rigor and problem-solving discipline.
  • Strong analytical skills with the ability to process operational or technical data and translate the output into a business result or opportunity.
  • Strong statistical analysis skills (process capability, equivalence studies, regression, ANOVA, DOE).
  • Proficient in SolidWorks (or equivalent) for tooling/fixture design. Well versed in GD&T and print generation.
  • Training and/or experience in formal problem-solving techniques (A3, 6-Sigma, 5 Why’s,DMAIC, etc.)
  • Excellent writing skills, able to write detailed reports, comprehensive manufacturing procedures and validation reports/protocols.
  • Ability to drive task clarity in a fast-paced environment with cross-functional stakeholders.
  • Demonstrate project management, planning, and leadership skills.
  • Strong communication skills, comfortable with leading and providing project status updates at the team, customer, and leaderships levels.
  • 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.
  • Certification or training in Lean Six Sigma methodology.
  • ISO 13485 (Medical Devices Quality Management Systems).
  • Project Management Professional (PMP).