Job Description

Careers that Change Lives
Mazor Robotics Ltd, a Medtronic company since December 2018, is a global pioneer of robotics technology for use during spinal procedures. Our site is now focused on developing and supplying high quality, innovative surgical planning and robotic solutions/products. Join us in working at a local and friendly site with global impact and reach.

A Day in the Life
This engineering position supports the Supplier Excellence program within the Mazor engineering organization. This position conducts engineering activities in support of manufacturing operations, which may include: process improvements, component and material changes, implementation of product design changes, Value Analysis / Value Engineering (VAVE), process validation (IQ, OQ, PQ), and manufacturing process transfer activities.
As a Senior Process Engineer you will conduct engineering activities and tasks in support of manufacturing requirements.

As part of your day to day you will:

• Develop and implement design improvements from design freeze and during mass-production.
• Design manufacturing processes, procedures, and production layouts for assembly associated with New Product Introduction (NPI).
• Design, qualify, document and validate assembly & test fixtures/Jigs and tools, release to production and service.
• Perform root causes analysis and implement corrective actions on equipment and manufacturing process issues.
• Support on-going production processes and equipment, train subcontractors & production line. Identify and implement opportunities for continuous improvement.
• Create or improve manufacturing assembly and testing instructions, production and assembly instructions.
• Provide technical evaluation and implementation plan input to the Corrective Action/Preventive Action (CAPA) program.
• Construction and management of product DMR including BOM, SOP's, Mechanical & electrical specs.
• Configuration management and Implementation of Engineering Changes/ECO.
• Identify, lead and implement data-driven quality, manufacturing, and cost improvement projects.
• Demonstrate experience leading engineering projects through phases of project lifecycle. Ability to use basic project management tools including project milestones, project schedules, resource management, and budget management.
• Ensures all engineering activity is in full compliance with applicable Mazor quality system requirements, regulatory approvals, and other agency requirements as-identified.
• Collaborate with R&D Designers, suppliers and Contract Manufacturers to design, characterize and qualify high capability processes producing consistent finished device medical products. This may include supporting process risk assessments (pFMEA), establishing process flows, developing control plans, conducting process validations (IQ, OQ, PQ), and setting product acceptance criteria.
• Strong understanding of Master Validation, including Validation Master Planning, Installation Qualification, Operational Qualification, and Performance Qualification.
• Provide technical oversight for manufacturing production performance, including product yield and cycle time management, and driving continuous improvements. Provide focus and clarity for continuous improvements using Key Performance Indicator (KPI) metrics.
• Working understanding of statistics, including sample size selection, data distribution analysis, capability calculations, Design of Experiments (DOE), and Analysis of Variation, and Statistical Process Control (SPC).
• Continuous improvement as a method for identifying opportunities for streamlining processes and reducing waste.
• Promote Value Analysis/Value Engineering as a systematic process to creatively assess and generate alternatives to identify essential functions at the greatest value. Value engineering through the systematic method to improve output by using rigorous examination of function.
• Implementation of manufacturing transfer requirements, for transition of products from Mazor to Contract Manufacturing, or between Contract Manufacturing facilities.

Working Relationships:

• Internal: R&D departments, QA/RA, Operations and Product
• External: Suppliers, Sub-Contractors, Contract Manufacturing

Must Have:

• BSc.in Mechanical Engineering
• At least 4 years proven experience in Engineering & manufacturing environments of multi-disciplinary products
• Advanced knowledge of job area with electromechanical experience
• Proven working experience with CAD
• Excellent communication skills, both verbal and written in English & Hebrew

Other Requirements for the role:

• "Hands on", Independendent, quick learner and a team player.
• Ability to set work direction, work independently, and communicate with a vast network of global stakeholders.

Nice to Have:

• Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD - significant advantage
• Experience in Medical Device companies - significant advantage
• Experience with design of surgical tools - advantage
• Six Sigma (DRM-DFSS) Green/Black Belt skills and experience - significant advantage
• Office proficient, experience with PDM/PLM systems, Priority

Your Answer
Is this the position you were waiting for? Then please apply directly via the apply button!

About Medtronic
Mazor Robotics, Ltd., a Medtronic company.
Together, we can change healthcare worldwide. At Medtronic, we push the limits of what technology, therapies and services can do to help alleviate pain, restore health and extend life.
We challenge ourselves and each other to make tomorrow better than yesterday. It is what makes this an exciting and rewarding place to be.
We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team.
Let's work together to address universal healthcare needs and improve patients' lives. Help us shape the
future.

Whatever your specialty or ambitions, you can make a difference at Medtronic - both in the lives of others and your career. Join us in our commitment to take healthcare Further, Together.

PHYSICAL REQUIREMENTS
The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer and communicate with peers and co-workers.
At Medtronic, you will find a diverse team of innovators who bring their unique backgrounds and their individual life experiences to work every day. We work hard to cultivate a workforce that reflects our patients and partners, we believe it's the only way to drive healthcare forward. We want to attract a diverse workforce, regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, veteran status, or any other characteristic protected by state or local law. Join us and bring the power of your point of view to our culture of collaboration and innovation. It is through strong diversity, inclusion and engagement that we can remain a leader in medical technology and solutions. And by embracing everything you have to offer --your unique perspectives, talents and contributions --we can live up to the promise of our Mission.

Additional Information

• Posting Date: Sep 8, 2022
• Travel: No