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 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.
- 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 or MS) in Biomedical/Mechanical Engineering or relevant experience.
- Minimum of 6 years’ experience in a medical device manufacturing environment designing and manufacturing Class 2 or 3 finished medical devices.
- Proficient in NPI and PDP and establishing of practices.
- 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).
If qualified, apply now. Job title and job location must be included in the application.
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Limitations and Disclaimer: The above job description is meant to describe the general nature and level of work being performed; it is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required for the position. Requirements are representative of minimum levels of knowledge, skills and/or abilities. To perform this job successfully, the employee must possess the abilities or aptitudes to perform each duty proficiently.