Standards & Compliance Engineer II - Hybrid (1-2 Remote)

Getinge; Wayne (NJ); Hybrid; USD 100,000 - 105,000; Full time

Benefits offered by this job

Health, Dental, and Vision insurance

401k plan with company match

Paid Time Off

Wellness initiative

Life Insurance

Disability Benefits

Job summary

Getinge is seeking an Engineer II, Standards and Compliance, in Wayne, NJ, on a defined-term assignment. The role focuses on executing product standards and compliance activities for complex electro-mechanical medical devices under guidance from senior engineers and SMEs.

You will leverage approved AI tools for first-line assessments, verify outputs, and organize evidence for decisions, maintaining clear records throughout the SAF process and related workflows.

Qualifications

• Bachelor’s degree in Engineering or closely related technical discipline.
• Typically 2–5 years of relevant experience in engineering, medical devices, or regulated product development.
• Ability to use approved AI tools to support first-line assessment while applying independent diligence.

Responsibilities

• Use approved AI tools to support initial standards and compliance screening and summarize information.
• Prepare, route, track, and follow up on Standards Assessment Forms and related records.
• Coordinate with CSA, SMEs, Regulatory, Quality and other stakeholders to obtain inputs.
• Maintain organized records of compliance asks, rationale, decisions and evidence.
• Facilitate Standards Action Board meetings and track follow-up to closure.

Skills

AI tools

Engineering judgment

Cross-functional collaboration

Documentation

Education

Bachelor’s degree in Engineering

Tools

AI tools

Job description

Getinge is seeking an Engineer II, Standards and Compliance, in Wayne, NJ, on a defined-term assignment. The role focuses on executing product standards and compliance activities for complex electro-mechanical medical devices under guidance from senior engineers and SMEs.

You will leverage approved AI tools for first-line assessments, verify outputs, and organize evidence for decisions, maintaining clear records throughout the SAF process and related workflows.