Senior Manufacturing Engineer

DESCRIPTION:

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.

RESPONSIBILITIES:

• 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.).

REQUIRED QUALIFICATIONS:

• (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.

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.
• Certification or training in Lean Six Sigma methodology.
• ISO 13485 (Medical Devices Quality Management Systems).
• Project Management Professional (PMP).