NPI Manufacturing Engineer

Job description

Primary Function of the Position Contribute your technical manufacturing and equipment design skills to a dynamic development team developing sensing platforms for minimally invasive robotic surgery. The role requires active participation in new product development teams that create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods while challenging new product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical instruments.

Essential Job Duties

• Create, maintain, and improve “low to mid-volume” manufacturing lines, specifying and/or refining BOMs, workflow processes, manufacturing plan and detailed work instructions Experience developing manufacturing lines - building prototype parts, training operators, identifying fixtures/tooling needed and conducting process validation
• Design, document, procure, qualify, implement, and improve fixtures, tools, and equipment
• Define and document PMC processes for newly introduced fixtures and tools
• Analyze manufacturing line from a risk perspective (PFMEA) to incorporate and validate critical tests used in manufacturing Responsible for the validation and qualification of manufacturing equipment and processes to production status leveraging standard qualification approaches (IQ/OQ/PQ)
• Provide production support of sustaining and startup manufacturing lines as needed
• Conduct testing of software releases before deploying on manufacturing line
• Identify and implement continuous improvement projects with respect to first pass yield, cycle time reduction, product reliability, capacity enhancement and cost reduction
• Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new products.

Maintains connections with leading manufacturing equipment suppliers and is aware of latest state of the art processes and equipment Execute and mentor others in manufacturing process validations, process FMEAs and other elements associated with production Master Validation Plans Maintain compliance with medical device quality system including corrective action closure and Change Order implementation Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies, and field returns Contribute to the establishment of group and individual objectives consistent with overall product development goals, including planning, priority setting, establishment of metrics, and effectively communicating progress Provide resource planning and budget estimates for product and process improvements, tooling development, and testing

Qualifications

Required Skills and Experience

Prior experience with managing product and process changes. Diligent organizational skills and proven ability to simultaneously work on several fast-paced projects. Must have experience releasing new product or manufacturing line through design/build process to production. Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams.

Proven technical, analytical, and troubleshooting skills. Required Education and Training Minimum BS degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience. Minimum 4 years of experience as design or manufacturing engineer supporting product with significant mechanical, electromechanical, or electro optical content. Working Conditions None

Preferred Skills and Experience

Meets at least five of the following criteria: Demonstrated successful transfer of complex manual processes to more automated processes. Prior responsibility for process, equipment, or product validation/verification Mechanical CAD software experience (SolidWorks or equivalent) Programming experience (LabVIEW Preferred) Experience with Lean Manufacturing/Six Sigma principles Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment Prior experience with complex device manufacturing Previous experience with ERP systems (preferred SAP) Experience with line duplication and/or transfer