Main characteristics
- Location
- Redwood City, California
- Company
- Sunrise Systems Inc
- Industry
- Retail|Stockroom|Inventory Specialist
Job summary
Job Description:The Sr. Manufacturing Engineer, Capital, supports a growing medical robotic business. Make an impact by improving current manufacturing processes, introducing new parts, and working with vendors.
You'll support the surgical robot manufacturing line to facilitate efficient operations, optimize existing processes, and ensure that production goals are met.
Individuals in this role will provide daily support for manufacturing operations, mechanical design improvements for existing processes and hardware.
Key Responsibilities:
Lead outsourcing efforts at contract manufacturers and process validation activities including IQ/OQ/PQ protocols and reports in ISO 13485 regulated environment.
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 capital equipment.
Create, maintain and improve pilot capital equipment manufacturing assembly lines, specifying and/or refining BOMs, work flow processes, manufacturing plan and detailed work instructions
Responsible for the validation and qualification of manufacturing equipment and processes leveraging standard qualification approaches (IQ/OQ/PQ)
Provide product and process DFx (Manufacturing, Assembly) input to enhance manufacturability of new and existing products
Develop and set up manufacturing assembly line, release and/or refine bill of materials (BOMs), work flow processes and detailed manufacturing process instructions (MPI) work instructions.
Conceives and plans complex projects and studies involving process or product costs, process control, or other labor related issues.
Provides estimates in the development and coordination of a 5 year capital budget.
Plans and performs a wide variety of manufacturing related assignments of major complexity requiring a high degree of technical and professional competence.
Recommends methods for improving worker efficiency and reducing waste of materials and utilities such as restructuring job duties, reorganizing workflow, and relocating workstations or equipment.
Design, document, procure, qualify, implement, and improve fixtures, tools and equipment
Analyze manufacturing line processes and test equipment from a risk perspective (pFMEA) to incorporate and validate critical tests used in manufacturing
Takes responsibility for maintaining compliance with medical device quality system including corrective action closure, discrepant material dispositions and ECO implementation
Provides technical support analyzing and /or performing failure analysis for discrepant production components, assemblies and field returns.
Qualifications - External
Qualifications
Education:
Minimum Bachelor's Degree in an Engineering, Biomedical, Physics or related discipline is required
MS degree in Engineering discipline or equivalent is preferred.
Experience and Skills:
Required:
Minimum 6 years experience as design or manufacturing engineer supporting product with significant mechanical / electromechanical content
Computer Aided Design Experience (CAD) is recommended.
Preferred:
Must possess strong communication skills to interface with technicians, product development, planning, purchasing, regulatory, inspection, customer support and clinical marketing teams
Prior responsibility for process, equipment or product validation/verification
Great attitude, eager, willing/able to take initiative, works well with others in team environment.
Other:
This position is 100% On-Site Monday- Friday in Redwood City, CA
Ability to travel up to 10% domestic and international
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