Sr Engineer - Medical Device Laboratory
SGS North America Inc.

Company Description

SGS is the global leader and innovator in inspection, verification, testing and certification services. Founded in 1878, SGS is recognized as the global benchmark in quality and integrity. With over 97,000 employees in 130 countries and operating a network of more than 2,400 offices and laboratories, we provide services to almost every industry by assuring quality and safety of products and services.

Trusted all over the world, SGS is a market leader because we put 100% passion, pride and innovation into everything we do. We encourage new ideas. We welcome people who challenge the way we do things. And we will be 100% committed to helping you reach your full potential.

Job Description

As Sr Engineer - Medical Laboratory, you will be involved in reading and implementing test standards as well as testing consumer products. Knowledge of electrical product testing and certification for Medical Devices is required. This individual will be able to work independently and with a team. Additional duties include assisting SGS leadership in the following areas: generation of quality procedures and work instructions; design and implementation of test fixtures; acquiring lab equipment and obtaining and maintaining accreditations.

Job Functions

• Review the design of medical electrical products against ANSI / AAMI / UL / CSA / EN / IEC / ISO standards
• Requires specific knowledge of IEC/UL 60601-1 and related part 2 standards for medical product safety standards (Qualification as a reviewer is preferred).
• Review Risk Management files to the requirements of ISO 14971
• Assist engineering team conducting tests
• Familiarity of IEC/UL 62368-1, IEC/UL 61010-1 and related part 2 standards is a plus
• Familiarity with battery testing and requirements also a plus - IEC 62133, IEC 69160, IEC 60086-X, UL 2054, UL 1642, UN 38.3 standards
• Assist to maintain and upgrade accreditation scopes
• Requires 10% travel
• Procurement of test equipment needed for lab scope expansion
• Ability to engage with sales to support customer inquiries
• Adhere to internal standards, policies, and procedures
• Perform other duties as assigned

• Bachelors of Science in Electrical Engineering, or equivalent education and experience (Required)
• 5+ years of experience in the certification, testing industry. (Preferred)
• Excellent interpersonal and communication skills, good team spirit and adaptability
• Ability to communicate effectively with SGS personnel and clients outside the US
• High level of accuracy
• Ability to assist and mentor staff
• Ability to prioritize workload and meet deadlines
• Ability to work in a fast-paced and dynamic environment, able to deal with ambiguity
• Ability to work on multiple tasks at the same time and prioritize them accordingly
• Ability to interpret specifications to satisfy customer requirements

• Language Skills: Advanced English (Required)
• Mathematical Skills: Intermediate (Required)
• Reasoning Skills/Abilities: Intermediate (Required)
• Great communication skills, with ability to interact with customers both written and verbal (Required)
• Familiar with operation of lab equipment including power supplies, hi-pot testers, and specialized medical test equipment (Preferred)
• Good technical/mechanical skills/aptitude (Required)
• Work independently and with limited supervision (Required)

• Intermediate proficiency in Microsoft Word and Excel (Required)

• Stand:
• Move or traverse:
• Sit:
• Use hands:
• Reach with hands and arms:
• Climb or balance:
• Stoop, kneel, crouch or crawl:
• Talk/hear:
• Taste/Smell:
• Lift/carry/push or pull: Occasionally 50 lbs