Principal Engineer - Manufacturing

Job Description

The position holder is responsible for the execution of process development deliverables and activities for Single Use Endoscopes (SUE) product development and launch to production. The position holder develops, improves, and implements the optimal manufacturing processes according to product delivery, operations, and business requirements to launch products effectively, on time, with high reliability and the right cost.
The position holder engages with cross functional development team (e.g. R&D, QA, etc) to influence and be influenced to ensure that operational and project goals and risks are balanced and managed proactively.
The position holder responsible for proactive engineering responses in alignment with Regulatory compliance requirements.

Job Duties

• Establish plans and complete process development activities to meet project goals including specification development, technology selection, process optimization, design for manufacturing evaluations, design reviews, prototype development, pilot build and product release readiness
• Ensure outstanding product development processes including FDA compliance and alignment to the phase gate product development process.
• Align with equipment engineering, industrial engineering, and production teams to ensure alignment and cohesiveness in overall process design and implementation to meet business, operational, and project needs
• Contribute to project status reporting, proactively identifying, resolving, and presenting any issues that may impact the team’s ability to meet key goals
• Evaluate and deploy cutting edge state of the art manufacturing methodologies to improve reliability, efficiency and cost metrics.
• Explore, evaluate, and implement optimal technologies and processing methodologies to improve quality and reliability and to reduce manufacturing cost. Cater technical solutions and process design to the product attributes (e.g. volume, reliability, cost targets)
• Serve as the “voice of the process” in cross functional project teams, ensuring that manufacturing process is adapted to product design requirements and vice-versa. Ensures that the evolution of product and process maintain in lock step through the development process.
• Contributes to the broader manufacturing strategy for products (e.g. make-buy, network strategy decisions, process modalities and automation, etc).
• Reviews technical deliverables, protocols, and reports from junior engineers as needed to provide technical coaching and ensuring top level technical rigor.
• Evaluate all available internal and external Operational SUE Product launches including manufacturing equipment, and Materials. Select and implement appropriate technologies that result in lower manufacturing cost, lower process variability and higher manufacturing capability.
• Provides Process Engineering in support all necessary projects and activities
• Own and drive process capabilities, and risk documentation for project assigned
• All Other Essential Duties as directed.

Job Qualifications

Required:

• B.S. degree in Engineering or a related field.
• An advanced degree (M.S.,PhD or MBA) is preferred.
• Minimum of 9+years of industry experience with a proven track record of successful product development within a regulated product development environment.
• Minimum of 8+ years with advanced degree (MS or MBA). 5+ years with PhD.
• Other Considerations (travel/hours availability, etc.): Travel up to 25%, mostly Domestic.

Preferred:

• Experience working in a multidisciplinary team setting bringing products from conception through market release and beyond. A record of commercialized products for volume production is required.
• Expertise with the development of processes, documentation, and execution of electro-mechanical medical device process development and validation is required.
• Experience partnering with external suppliers for the development of new processes and technologies as demonstrated with commercialized products.
• Able to think both logically and creatively and possess sound reporting abilities.
• Advanced knowledge of core engineering tools. For example: 6-sigma, FMEA, Risk Analysis, Process Mapping, Standard Work Instructions, Lean Manufacturing, Manufacturing Work Instruction Creation, DOE methods, Process Characterization, Verification & Validation activities.
• Advanced technical expertise in one or more sub-specialties of process engineering (e.g. injection molding, extrusion, vision systems, PCBA, CAD, stamping, machining, additive manufacturing, etc).
• Knowledge of and experience with financial elements of process engineering (e.g. cost modelling, cost structure optimization).
• Experience in planning and executing process characterization and validations studies.
• Experience in planning and implementing process control systems.
• Experience test method development and validation.