Industrial Manufacturing Engineer 4 - Sunrise Systems Inc
Redwood City, CA 94065
About the Job
Job Title: Industrial Manufacturing Engineer 4
Job ID: 24-01210
Location: Redwood City, CA
Duration: 09 Months contract on W2
Job Description:
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.
The hourly rate for this position is 78.25 per hour.
Compensation:
Factors that may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate].
Contact:
Durga Prasad: Durgaprasad.B@sunrisesys.com | 732 313 0251 URL:www.sunrisesys.com
Job ID: 24-01210
Location: Redwood City, CA
Duration: 09 Months contract on W2
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.
The hourly rate for this position is 78.25 per hour.
Compensation:
Factors that may affect starting pay within this range may include [geography/market, skills, education, experience, and other qualifications of the successful candidate].
Contact:
Durga Prasad: Durgaprasad.B@sunrisesys.com | 732 313 0251 URL:www.sunrisesys.com
Source : Sunrise Systems Inc