Advance Medical Project Engineer

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.

We are seeking an experienced and detail-oriented Advance Medical Project Engineer to lead the evaluation and testing of medical and laboratory equipment in accordance with IEC 60601-1 and/or IEC 61010-1 standards. In this role, you will play a critical part in ensuring our products meet global safety and compliance requirements throughout the development lifecycle. The ideal candidate will bring a deep understanding of regulatory standards, strong technical and analytical skills, and a collaborative approach to working across engineering, quality, and regulatory teams to deliver safe and reliable products to market.

Roles and Responsibilities:

• Plan, conduct, and document product safety evaluations in accordance with IEC 60601-1, IEC 61010-1, and applicable collateral/particular standards.
• Interpret and apply the safety standard requirements to new and existing medical and laboratory equipment designs.
• Conduct hazard analysis and risk assessments as per ISO 14971 and integrate results into safety compliance strategies.
• Set up and conduct in-house tests including leakage current, dielectric strength, mechanical strength, and environmental tests as required by standards.
• Generate detailed test reports and maintain traceable records of evaluation results.
• Support preparation of regulatory submissions (FDA, EU MDR/IVDR, etc.) by providing safety-related content.
• Monitor changes in applicable standards and regulations and assess their impact on product compliance.
• Recommend and implement process improvements to enhance safety evaluation efficiency and compliance accuracy.
• Provide oral and written high-quality status updates and meet project commitments.
• Assist with business development activities, e.g., defining project scope, timeline, and budget for quotes.
• Facilitate the development and training of engineers and perform other duties as assigned.
• Maintain and increase job knowledge by studying state-of-the-art, ongoing research in the field, etc.
• Mentor junior engineers.
• Serve as lab reviewer for other engineering projects and provide feedback on submitted documentation, e.g., test reports, test plans, noncompliance reports, etc.
• Participate in educational opportunities and read professional publications.
• Maintain personal networks and participate in professional organizations.

Skills/Competencies:

• Ability to read wiring schematics.
• Knowledge of various schemes and their requirements, e.g., FDA submission, CB Scheme, NRTL program, etc.
• Ability to communicate effectively with SGS personnel and clients.
• High level of accuracy and good presentation skills.
• Ability to self-prioritise workload and meet deadlines.
• Ability to work in a fast paced and dynamic environment, able to deal with ambiguity.
• Willingness to collaborate.
• Ability to work on multiple tasks at the same time and prioritize them accordingly.
• Ability to interpret specifications to satisfy customer requirements.

Profile of the position (Requirements & Qualifications):

• BSEE or equivalent degree, MS preferred.
• 5+ years in the Testing, Inspection and Certification (TIC) sector.
• In-depth knowledge of IEC 60601-1 and IEC 61010-1 and related -2 standards for medical product safety.
• Able to travel outside the US.

Benefits

• Competitive salary.
• Comprehensive health, dental, and vision insurance for full time employees.
• Retirement savings plan.
• Continuous professional development and training opportunities.
• A dynamic, collaborative work environment.
• Access to cutting-edge cryptographic technology and tools.

Physical Demands of the Job

• Stand: Occasionally
• Move or traverse: Frequently
• Sit: Constantly
• Use hands: Constantly
• Reach with hands and arms: Occasionally
• Climb or balance: Occasionally
• Stoop, kneel, crouch or crawl: Occasionally
• Talk/hear: Constantly
• Taste/Smell: Occasionally
• Lift/carry/push or pull: Occasionally 30 lbs

Additional information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression, genetics, status as a protected veteran, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities or requirements, but a general description of the job. Nothing contained herein restricts the company’s rights to assign or reassign duties and responsibilities to this job at any time.

If you are applying for a position within the United States and you have difficulty completing the on-line employment application because of a disability, please call 201-508-3149 for assistance and leave a message. You will receive a callback.  Please note, this phone number is not for general employment information but is only for individuals who are experiencing difficulty applying for a position due to a disability.