Sr. Manufacturing Engineer

We are looking for a Sr. Manufacturing Engineer to join our team!

Location: Netanya

BioProtect Ltd is a leading medical start up in radiation protection technology. We offer spacers protecting healthy tissue during radiation oncology treatments, based on proprietary biodegradable balloon technology. The balloons suit a wide range of clinical applications in the fields of oncology and general surgery. The company’s first product, the BioProtect Balloon Implant, protects healthy tissue in patients undergoing radiation therapy for prostate cancer. Recently, BioProtect was acquired by Olympus Corporation and now operates as part of the Olympus Group.

The opportunity:

Support the day-to-day operation of the manufacturing line or value stream through:

Optimization of processes for manufacture and product flow. Assist the development of facilities layout for equipment moves and additions using Lean Manufacturing principles. Perform time studies to capture continuous improvement activities. Initiate and implement change orders through the change order management system. Develop and update process and material specifications as required. Coordinate operator training for new and existing processes, products, and equipment. Coordinate and utilize external resources such as vendors and sister sites to resolve technical issues or improve processes or products. Write capital expenditure requests, gain approval, coordinate the purchase & installation of equipment, and track costs. Validation of equipment and processes as required when making process improvements.

In this position you will be asked to:

• Complete process development activities under the guidance and leadership of R&D engineers to meet project goals including process characterization and optimization, prototype development, process validation, pilot build, process control and product release readiness
• Ensure outstanding product development processes including FDA compliance and alignment to the Phase Gate product development process
• Responsible for the development and validation of capable production and test processes that meet operational objectives as assigned
• Authors test protocols and reports and related technical documentation in accordance with good documentation practices to ensure that studies and tests are in executed in an effective and compliant manner.
• Explore, evaluate, and implement optimal technologies and processing methodologies to improve quality and reliability and to reduce manufacturing cost. Cater technical solutions and process design to the product attributes (e.g. volume, reliability, cost targets)
• Executes process validation and test method validation activities with statistically relevant and robust methods.
• Contribute to process risk analysis and control systems development and implementation.
• Correspond with production teams-,manufacturing supervisors, engineers and suppliers to optimize existing processes.
• Production line support including but not limited to implementing process improvements, troubleshooting equipment, addressing process questions, setting up KanBan’s and capacity planning.
• Works with other functions to standardize, leverage and implement engineering tools and establish best-demonstrated practices
• Provides Process Engineering support all necessary projects and activities
• Execute and drive process capabilities, and risk documentation for project assigned
• Lead cost improvement projects.

A successful candidate will have the following qualifications:

• A minimum of a Bachelor’s degree (B.Sc.) in science or engineering discipline.
• Minimum years of experience: 5+ years with a bachelors, 4+ with a masters, working in a manufacturing engineering or related role. Experience working in a regulated medical device environment is a strong plus.
• Expertise with the development of processes and related documentation. Strong good documentation practices
• Working knowledge of some or all core manufacturing engineering tools. For example: 6-sigma, FMEA, Risk Analysis, Process Mapping, Standard Work Instructions, Lean Manufacturing, Manufacturing Work Instruction Creation, DOE methods, Process Characterization, Verification & Validation activities (GDP) are required.
• Able to work well in a close team environment.
• Technical writing: may include protocols, reports, and validations.
• Time management skills allowing for working on multiple projects at once.
• CAD experience a plus

BioProtect is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.