Product Safety Operations Manager

X4 Engineering; Santa Clara (CA); On-site; USD 140,000 - 190,000; Full time

Job summary

X4 Engineering is seeking an Operational Manager of Product Safety to lead the strategic and daily execution of safety compliance across a diverse product portfolio in Santa Clara, CA. You will ensure compliance with international standards for medical devices, lab equipment, IT and household appliances, and manage the safety lab and staffing.

You will quote projects, support sales with technical input, and represent the lab in external audits.

Qualifications

• Deep knowledge of IEC 62368-1, IEC 61010-1 and IEC 60601-1 required.
• Experience leading a product safety testing laboratory.
• Ability to review projects as technical reviewer and lead external audits (A2LA, IECEE, SCC, OSHA).

Responsibilities

• Lead strategic and day-to-day safety compliance across a diverse product portfolio.
• Manage safety laboratory and train/mentor staff.
• Support project scoping and quotations as needed.
• Travel up to 25% as business needs dictate.

Skills

IEC 62368-1 knowledge

IEC 61010-1 knowledge

IEC 60601-1 knowledge

Leadership/Management

Test planning

Education

Four-year college degree – Engineering (or equivalent)

Tools

Test instruments

Job description

As the Operational Manager of Product Safety, you will lead the strategic and day-to-day execution of safety compliance across a diverse product portfolio. You will be responsible for ensuring that all products meet stringent international standards for medical devices, laboratory equipment, information technology, and household appliances. You will be responsible for team training as needed along with managing the safety laboratory. You will also be supporting as needed project scoping and quotations. The Department manager must have great depth of knowledge within IEC 60601-1, IEC 62368-1 & IEC 61010-1. IEC 60335-1 is plus. As the department manager you will be responsible for lab’s upkeeping.

Tasks and Responsibilities:

• Require standard knowledge needed in IEC 62368-1, IEC 61010-1 & IEC 60601-1. IEC 60335-1 is plus.
• Quoting skills for IEC 62368-1, IEC 61010-1 & IEC 60601-1 are a must. IEC 60335-1 is plus.
• Read and determine applicability of national codes and standards clauses for the EUT (equipment under test).
• Test products in accordance with standards and requirements. Core tests include, but are not limited to power input, leakage current, dielectric, temperature, stability, mechanical hazards, flammability, abnormal and single fault, IP testing and others as applicable per project and compliance requirements.
• Read and understand schematics and manufacturing instructions.
• Identify and locate test instruments and equipment required for testing and project execution & also able to set up test plans.
• Perform preliminary design reviews (PDR) both on and off site.
• Train and mentor less senior technical staff.
• Support sales in project communication with customers
• Attend product reviews to provide technical support.
• Review technical reports & Test plans.
• Be able to manage multiple projects.
• Manager product safety team of engineers
• Ensure the lab’s equipment is up to date. Support lab’s calibration needs for equipment.

Qualifications:

• Four-year college degree – Engineering discipline or equivalent work experience.
• At least 7+ years of product safety experience in Testing inspections certification laboratory specifically within combination of IEC 62368-1, IEC 61010-1 & IEC 60601-1
• Pervious role in management required. 2+ years.
• Should have the ability to review projects as technical reviewer.
• Can test any standard outlined above from start to finish.
• Understand how to represent the lab in external audits (A2LA, IECEE, SCC & OSHA)
• Has great depth of knowledge of IECEE rules and regulations.
• The ability to travel as business needs to dictate up to 25%.
• Able to go locally to client sites for any testing when needed

Reporting:

This position reports directly to Santa Clara, CA Manager of Product Safety.