NPD Engineer II

Located in beautiful Santa Rosa, CA, SMC, Ltd. is a globally recognized premium supplier to the medical market with locations throughout the world. People committed to speed, technology, and exceptional performance are the cornerstone of our organization. Comprised of dedicated people and decades of manufacturing experience, we have continued to experience strong growth and currently have outstanding career opportunities for equally dedicated people.
In the role of an NPD Engineering , you will be responsible for performing multiple related duties in conjunction with other employees and departments contributing to the overall team effort, efficient process, and safe working environment. This position includes many essential components for successful and efficient manufacturing, and as such, shares full responsibility for the final product delivered to the customer.
Essential Job Duties and Responsibilities:

• Contributes to the successful introduction of assigned new projects into production.
• Has high levels of engagement with all internal departments/functional groups, and with the customers.
• Fosters teamwork while participating in cross-functional project teams to the successful execution of project requirements and goals.
• Contributes to the development of validation strategies for new products, transfers and/or process improvements.
• Provides project team support for product Design for Manufacturability (DFM) of molded components as well as assembly products, working with material/supplier sourcing, manufacturing engineering, quality, and other Subject Matter Experts (SME).
• Provides project team support for mold, fixturing, work cell layout, and automation design, working with material/supplier sourcing, manufacturing engineering, quality, and other Subject Matter Experts (SME).
• Participates in the development implementation of manufacturing processes for molded components and assemblies.
• Acts in accordance with ISO and other regulatory requirements, and company procedures.
• Supports the initiation, author, and approval of validation protocols and completion reports as needed.
• Supports the initiation, author, and approval of work instructions and other manufacturing process documentation required as part of a standard Device Master Record (DMR).
• Participates in the management of line and equipment validation and qualification activities including MSA, IQ, OQ, PQ, and PPQ.
• Evaluates existing product flow, investigate and identify new technology developments including automation-based solutions, and other technical improvements to drive process improvements to enhance quality, safety, customer satisfaction, production standards, and cost efficiencies.
• Applies Lean Manufacturing and Six Sigma principles for new product launches.
• Participates in the development, installation, calibration, operation, maintenance, and repair of new, modified and/or existing equipment and fixtures.
• Creates and controls project Work Breakdown Structures (WBS), project gantt charts, action plans, status updates, and budge tracking controls.
• Generates, reviews and approves ECO's, CAR's, MRB's, complaints.
• Communicates specifications for BOM creation.
• Provides information for BOM updates.
• Provides technical troubleshooting support for both NPD and Production.
• Participates in the Release to Manufacturing process for assigned projects.
• Has all the documents needed for a project and coordinate with appropriate functional group (Document Control, QA, Scheduling, etc.) to have them in IQMS at the appropriate time to prevent any delays in the project timeline.
• Works with Materials department to source new materials and equipment as needed.
• Obtains supplier quotes and complete requisitions for purchasing.
• Performs all other duties as assigned.

ADA Requirements:

• Typically sits, grasps items and performs keyboarding for frequent operation of a computer
• Stand, walk, bend, reach or otherwise move about regularly
• Lift, move, or otherwise transfer items up to 40 lbs. occasionally, >20 lbs. frequently
• Occasional exposure to typical machine shop physical hazards
• Travel by air or car frequently

We are committed to fair and equitable hiring with salaries based on relevant factors, such as work experience, education, and certifications. Toward the principle of equal pay for equal work, we post and hire within defined salary ranges. We ask all applicants to review salary ranges for each posted job opportunity, as we will not hire outside the predetermined range.
Salary Range $72,000 - $103,000
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