Senior NPI Manufacturing-Mechanical Engineer
1266 Kifer Road Sunnyvale, CA 94086
Primary Scope of Position:
You will own the manufacturing content for new product introductions and participate with product development teams that specify, build, test and challenge new product designs to improve efficacy, reliability, serviceability, manufacturability and cost.
Roles and Responsibilities:
- Provides product and process DFx (Manufacturing, Assembly) input to Product Development Engineering to enhance manufacturability and product cost.
- Takes ownership of new products during pilot production phase through successful and sustained project launch. This includes driving new product introduction schedules, resolving manufacturability issues, and driving improvements for cost and efficiency.
- Proactively evaluate and challenge designs for technical merit, reliability, serviceability and manufacturability working with the design team to realize optimal outcomes.
- Creates an efficient “ low- to mid-volume” manufacturing assembly line, specifying and/or refining BOMs, workflows and detailed work instructions. This includes developing the process flow, and manufacturing process instructions (MPIs), including test procedures
- Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/DQ/PQ/PPQ).
- Responsible for maintaining compliance with medical device quality system requirements including corrective/preventive action closure, discrepant material dispositions and change order creation, review and implementation.
- Provide technical support for failure analysis of discrepant production components, assemblies and field returns.
- Leads/participates in continuous improvement initiatives focused on material cost reduction, capacity enhancement, and streamlining of supply chain.
- Mentors and sets project tasks for Manufacturing Engineers on their specific project team and on other teams as needed to further company expertise & effectiveness.
- This role requires active participation to create and refine electro-mechanical components, assemblies, process documentation, tooling and test methods for robotic surgical instruments. The successful candidate will have achieved the following:
- BS Mechanical Engineering; MSME preferred
- 7+ years’ experience as design or manufacturing engineer supporting product with significant mechanical content.
- Solid modeling/CAD experience (SolidWorks preferred).
- Demonstrated understanding of manufacturing processes including injection molding, machining, stamping, laser welding, design of experiments, and capability analysis.
- Strong foundation in design, fabrication and assembly of complex assemblies with demonstrated knowledge of mechanical assembly techniques, test methods included gage R&R analysis, DFx, and lean principles.
- Strong technical skills in prototyping, tooling development, process engineering, and troubleshooting.
- References who will validate you as a strong a team player, self-starter, and possessing a can-do attitude!
- Strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, clinical marketing organizations, and suppliers.
- Strong problem-solving ability, including demonstrated ability to effectively design, execute, report on, and draw conclusions from experiments.
- Excellent organization, follow-up and documentation skills.
- Comfortable interacting with technicians, engineers, and management all on a regular basis.
Highly preferred skills & experience:
- Electromechanical new product development experience preferred.
- Experience in an ISO 13485, ISO 9001, or medical device manufacturing environment a plus.
- Machine tool experience a plus.