STANLEY Healthcare, now Securitas Healthcare and part of Securitas, empowers caregivers to deliver connected, productive, and safe care. Our innovative portfolio of solutions helps hospitals, clinics, and senior living organizations protect people, use their assets efficiently, and understand their operations for a caring and healing environment. With deep roots in healthcare and a commitment to our customers’ long-term success, we are proud to work with over 15,000 providers worldwide across the care continuum. For more information, visit us at stanleyhealthcare.com.

We need the best people to help us deliver on that mission. People who are inspired by our vision. People with individual imaginations, perspectives, and experiences. People who don’t just join us but add to us.

Candidate must be located within commuting distance to Lincoln, NE. This position is onsite.

Position Summary

The Compliance Engineer will report directly to the Director of QA/RA and support all regulatory requirements and industry certifications in support of product design. This individual will collaborate across functional teams to develop positive and proactive approaches to regulatory compliance, ensuring product and company compliance with global product standards.

Position Responsibilities

• Ensure new and existing products meet compliance with global standards organizations (UL, FDA, CE, UKCA, EN and FCC).
• Co-ordinating in product testing and safety agency testing including software, Hardware, and product safety & associated markings.
• Working closely with independent test agencies to carry out plans through completion including managing, evaluating, and analyzing detailed test reports and providing improvement suggestions, product labeling etc.
• Creating and maintaining regulatory database and summary reports to support management efforts to track and trend filing and registration requirements. Creating processes to ensure the compliance team communicates policies and processes as it relates to Regulatory Compliance.
• Providing regulatory support to Sustaining Engineering, R&D, QA, and Engineering in generating risk analysis such as Hazard Analysis. Submitting Document Change orders (ECO/Agile) for approvals.
• Assist in identification & selection of new and alternate components.
• Coordinate product testing and safety agency testing including Software, Hardware, and product safety & associated markings and technical construction files for UK/EU compliance.
• Work with external approval agencies to obtain orderly and accurate product approvals
• Execute Product Risk Assessments and Functional Evaluations, collect supporting information and provide recommendations and guidance to the Business.
• Ability to lead investigations and remedy dispensation of product failures to a successful conclusion.
• Own the global compliance budget for Stanley Products and Solutions
• Working with Third party vendors to obtain international Certification and type approval for wireless products.
• Lead all regulatory audits
• An understanding of EN 303:645, IEC 62443, UL62368, UL294, etc.

Required Qualifications

• Bachelor’s Degree in Engineering

Preferred Qualifications

• Master’s Degree in Engineering
• 3+ years’ experience successfully submitting and managing regulatory and industry certifications
• 1+ years of engineering experience
• Demonstrated project management experience
• Excellent verbal and written communication skills.
• Excellent prioritizing, organizational, and interpersonal skills.
• Excellent documentation skills including record maintenance/ tracking and understand document traceability.
• A detail-oriented individual with a “can-do” attitude and ability to work in a team environment
• Ability to work in a fast-paced environment, with multiple tasks/projects