NPI Manufacturing Engineer
About The Position
Contribute technical manufacturing and equipment design skills to a development team creating sensing platforms for minimally invasive robotic surgery. Participate in new product development teams developing and refining electromechanical components, assemblies, process documentation, tooling, and test methods. Challenge product designs to improve efficacy, reliability, manufacturability, and cost for robotic surgical instruments. The role creates and improves low- to mid-volume manufacturing lines and supports new product introduction, production qualification, sustaining operations, continuous improvement, and manufacturing process validation. It also provides technical support for production discrepancies and field returns, contributes to product development objectives, and plans resources and budgets for improvements, tooling, and testing.
Requirements
- Experience managing product and process changes.
- Strong organizational skills and the ability to work simultaneously on several fast-paced projects.
- Experience releasing a new product or manufacturing line from design/build through production.
- Strong communication skills for interfacing with technicians, product development, planning, purchasing, regulatory, inspection, customer support, and clinical marketing teams.
- Proven technical, analytical, and troubleshooting skills.
- Minimum bachelor's degree in Mechanical Engineering, Mechatronics, Electrical Engineering, Industrial Systems Engineering, or similar relevant experience.
- Minimum four years of experience as a design or manufacturing engineer supporting products with significant mechanical, electromechanical, or electro-optical content.
Nice To Haves
- Demonstrated successful transfer of complex manual processes to more automated processes.
- Prior responsibility for process, equipment, or product validation/verification.
- Mechanical CAD software experience, such as 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.
- Experience with ERP systems; SAP preferred.
- Experience with line duplication and/or transfer.
- Meets at least five of the listed preferred criteria.
Responsibilities
- Create, maintain, and improve low- to mid-volume manufacturing lines, including BOMs, workflows, manufacturing plans, and detailed work instructions.
- Develop manufacturing lines by building prototype parts, training operators, identifying fixtures and tooling, 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 lines for risk using PFMEA and incorporate and validate critical manufacturing tests.
- Validate and qualify manufacturing equipment and processes for production using IQ/OQ/PQ approaches.
- Provide production support for sustaining and startup manufacturing lines as needed.
- Test software releases before deploying them on manufacturing lines.
- Identify and implement continuous improvement projects involving first-pass yield, cycle time, product reliability, capacity, and cost.
- Provide product and process DFx input, including manufacturing and assembly considerations, to improve manufacturability of new products.
- Maintain connections with manufacturing equipment suppliers and stay aware of state-of-the-art processes and equipment.
- Execute and mentor others in manufacturing process validations, process FMEAs, and other elements of production Master Validation Plans.
- Maintain compliance with the medical device quality system, including corrective action closure and Change Order implementation.
- Provide technical support by analyzing or performing failure analysis on discrepant production components, assemblies, and field returns.
- Contribute to group and individual objectives, including planning, prioritization, metrics, and communicating progress.
- Provide resource planning and budget estimates for product and process improvements, tooling development, and testing.
Benefits
- Market-competitive compensation packages including base pay, incentives, benefits, and equity.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
