Manufacturing Engineer

Job Description of Manufacturer Engineer:

A Day in the Life:

The Manufacturing Engineer position provides the technical expertise and leadership that drive sustaining and improving the Mazor Robotic Surgical System. The engineer will drive ECNs (as the Change Owner), and implement product and manufacturing improvements, based on investigations completed together with system, quality, and clinical experts. These ECNs may include a range of updates, including product changes, process improvements, the introduction of new equipment, and other related manufacturing activities.

The Manufacturing Engineer provides an interface between the suppliers and Mazor resources such as Released Product Management (RPM), Regulatory, Quality, System Engineering, etc. to help troubleshoot issues, drive improvements, and execute cross-functional projects requiring support outside the site. As the change owner, the Manufacturing Engineer (with the aid of a dedicated team) will be responsible for the change's end-to-end leadership, including Technical, logistics, Cost, Regulation, Supplier communication, etc.

The Manufacturing Engineer will be working in the mind frame of risk-based assessments and conformity to regulation as well as V&V processes. The manufacturing engineer will have the knowledge and expertise to use Mechanical and statistical analysis as well as an excellent understanding of GD&T (Geometric Dimensioning and Tolerancing), Manufacturing technologies, CAD design skills, and problem-solving techniques to achieve the best solution possible for his projects.

The Manufacturing Engineer will assist with the build of the product’s BOM (Bill of Material) as well as the DMRs defining the process flow and acceptance tests.

As part of a day to day, the Manufacturing Engineer will:

• Own Engineering changes and be responsible for the ECNs from end to end.

• Plan, update, and report on project progress

• Write and update technical documentation ( work instructions, test procedures, etc.)

• Prepare and present technical reviews (TRR, DRs, CCB)

• Construction and management of product DMR including BOM, SOPs, Part Drawings, and Mechanical & electrical specs.

• Design, qualify, , and validate assembly & test fixtures/Jigs and tools, release to production and service.

• Collaborate and communicate with a vast network of global stakeholders.

Note: The following are meant to be representative but not necessarily all-inclusive of the duties and responsibilities for this position title.

Must Haves

BASIC QUALIFICATIONS:

• BSc.in Mechanical Engineering with at least 2 years of relevant experience.

• Proven experience in Change Control processes (ECO, ECN ..)

• Experience in mechanical design, design for manufacturability, engineering prints, and GD&T.

• Significant experience in CAD tools such as SolidWorks.

• Strong knowledge of manufacturing processes.

• Excellent English communication skills both oral and written. Effectively communicate and works cooperatively with others as part of a team.

• Highly organized and with strong initiative.

• Excellent problem-solving skills.

• Team player with the ability to work independently.

• Able to effectively work with cross-functional teams in a multi-disciplinary matrix organization.

• Passionate hands-on approach.

• Proven experience in multi-disciplinary products

• Experience or extensive knowledge of at least 2 related disciplines from the below:

1. Design experience of subsystems in a multidisciplinary machine.

2. Sustain engineering experience

3. NPI experience

• Knowledge and experience in motion control

• Part & Process validation experience

• Expert in maintaining, writing, and executing Quality action, e.g., Failure Modes and Effects Analysis (FMEA)

• Transportation independence, and the ability to travel to CM facilities.

DESIRED/PREFERRED QUALIFICATIONS (optional):

• Experience in Medical Device companies or other highly regulated industries

• Understanding and knowledge of relevant regulations and standards FDA QSR, ISO 13485, ISO 14971, MDD-significant advantage

• Knowledge of quality systems (QMS)

• Experience in research and development of multidisciplinary systems.

• Excellent written and verbal communication skills in English

• Experience with the design of surgical tools

• Experience in working with PLM systems such as WCL and WGM.

• Quality-related knowledge e.g., SPC, ANOVA, and Gauge R&R.