Pay: $50.00-$75.00/hr - Paid Weekly
M-F 8am to 5pm
On-site in Campbell, CA 95008
10-12 month contract
Must have recent catheter experience
EDUCATION/EXPERIENCE:
- BS in Engineering or related discipline and 5+ years of related experience; or MS in Engineering with 3+ years of related experience; or equivalent combination of education and work experience .
- Knowledge of and experience in pilot/production line set up and validation in Controlled Environment.
- Experience working under quality systems designed to meet governmental regulations such as FDA QSR, ISO 13485, and the MDD.
- Ability to detail project plans effectively.
- Familiar with GMP, GDP procedures and requirements.
- Excellent communications skills (both written and verbal) required.
- Ability to work independently or in team setting required.
- Project management experience preferred.
- Must be able to travel.
SUMMARY:
This position is responsible for the following areas: In-House and Contracted Manufacturing, Manufacturing Engineering, and Equipment Planning/Engineering in accordance the company’s Quality System and customer requirements. This position will ensure that assigned projects product/s are designed to facilitate manufacturability and will be responsible for technology transfer to manufacturing and ultimately scalability for commercialization.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned on an individual basis:
- Establish and manage in-house and/or contract manufacturing activities and relationships to ensure products are manufactured in accordance with product plans and quality/regulatory requirements.
- Work with Supply Chain to ensure inventory of raw materials and components are available per the planned build schedule, manage and be accountable for material issued to production/projects.
- Develop manufacturing processes and Manufacturing Process Instructions (MPI’s) and lot history records (LHR’s) in collaboration with R&D and Quality.
- Lead the construction of prototypes for new products/processes or current product enhancements.
- Perform time studies for each manufacturing process and identify process development initiatives.
- Work with Quality personnel to define in-process inspections and testing and resolve quality and yield issues through continuous improvement projects.
- Provide oversight and coordinate multi-functional operations project team activities from early project conceptualization through clinical testing.
- Create, maintain, and manage manufacturing tasks of project schedule, and ensure that critical timelines and/or budgets are established and met.
- Participate in manufacturing team meetings to ensure communication between members.
- Develop positive proactive working relationships with team members and other staff members.
- Develop manufacturing specifications for products; coordinate all process validation activities with Quality- IQ/OQ/PQ.
- Determine tooling and equipment needs for the timely and cost-effective manufacture of products
- Work with R&D staff to ensure smooth transition of products into manufacturing while assuring manufacturability, achieving cost targets and conformance with regulatory and Company requirements.
- Work with suppliers to ensure parts/services are properly documented and meet specifications
- Manage specifications for sub and final assemblies; identify tooling requirements – design/document/procure/verify tooling.
- Establish manufacturing line and approve DCO’s for manufacturing engineering.
- Train/Certify the MPI Trainer for manufacturing process instructions; may train other staff as needed.
- Using continuous improvement techniques, work with Quality Assurance to identify and implement programs to drive down cost and improve yield and reliability.
- Plan equipment and workflow layouts in manufacturing areas. Manage manufacturing equipment design and development to ensure that equipment is cost effective and meets manufacturing specifications and maintain and coordinate all calibration and preventive maintenance activities in conformance with the Company’s Quality System requirements.
- Actively promote and support the Quality Management System, Quality Objectives, and Quality Policy.
- Assure that you and functional subordinates (if applicable) are trained on all applicable procedures and processes according to Good Manufacturing Practices, applicable FDA and Regulatory requirements.
- Actively promote and support the company’s Management Review process.
- Inform responsible personnel of concerns involving product quality.
- Perform job functions in a safe and effective manner.
- Other duties as assigned.
Benefits (employee contribution):
- Health insurance
- Health savings account
- Dental insurance
- Vision insurance
- Flexible spending accounts
- Life insurance
- Retirement plan
All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
