Job Description
Job Title: Lead Compliance Engineer, R&D
Salary: Mid-point and target $140-$160 absolute MAX + 12% bonus
Location: Wilmington
Duration: PERM
Shift: M-F 1st shift, flexible start times
Key Responsibilities:
Salary: Mid-point and target $140-$160 absolute MAX + 12% bonus
Location: Wilmington
Duration: PERM
Shift: M-F 1st shift, flexible start times
Key Responsibilities:
- Develop and implement compliance strategies for global regulatory standards (EU MDR, EMC/EMI, safety compliance, etc.) throughout the product lifecycle.
- Serve as the primary technical expert for regulatory compliance, supporting Program Management, Regulatory Assurance, and R&D teams.
- Participate in product design reviews, identify applicable regulatory standards, and provide training to prevent compliance issues.
- Oversee EMC, environmental, and IEC 60601-1 compliance testing at certified labs; act as liaison with agencies such as UL, CSA, TUV, BSI.
- Drive compliance activities for new product launches, post-launch changes, and corrective actions to ensure ongoing regulatory compliance.
- Support internal and third-party audits, prepare and review documentation for test labs and regulatory bodies.
- Create compliance program plans, certification test plans, verification procedures, and reports.
- Collaborate with engineering, marketing, systems, and manufacturing teams to implement compliance requirements into product definitions.
- Manage multiple projects and priorities, contributing to CAPA, cost reduction, EOL, and operations support projects.
- Mentor and train junior engineers as needed.
- Sit, stand, walk, reach, stoop, kneel, crouch, crawl.
- Lift/move/carry products up to 40 pounds.
- Exposure to moving mechanical parts, vibration, and moderate noise.
- Bachelors degree required; masters or PhD in a technical field strongly preferred.
- 8+ years of experience (or 6+ years with Masters, 3+ years with PhD) in compliance testing for product devices and international certifications.
- Experience with wireless technologies (Wi-Fi, RFID) and electrical test equipment (spectrum analyzers, vector network analyzers, signal generators).
- Strong understanding of medical device compliance and safety standards, device manufacturing, and product lifecycle processes.
- Proficient in EMC design concepts, lab test equipment (multi-meters, oscilloscopes, spectrum analyzers, etc.).
- Ability to troubleshoot and resolve complex EMC issues.
- Experience leading cross-functional teams and projects.
- Logical thinking, mature engineering judgement, and strong analytical/problem-solving skills.
- Effective collaboration and communication skills with technical and non-technical colleagues.
- Proficiency in revision control and at least one software language (e.g., Python).
- Familiarity with FDA, FAA, DoD, ISO environments and risk assessment management.
- Proficient in Microsoft Office Suite (Excel, Word, PowerPoint).
- Ability to mentor and train junior engineers is a plus.
Numbers & Facts
| Location | Wilmington, DE |
| Industry | Staffing/Employment Agencies |
| Salary | $140–$160 Per Hour |
| Company Size | 500 to 999 employees |
| Year Founded | 1999 |
| Website | https://www.csetalent.com/ |
About Company
Connexion is an award-winning professional staffing firm that strives to be the unrivaled staffing solution for job seekers by expertly connecting talent with opportunity. Over the last 20 years Connexion has built the most admired team of staffing experts in the industry. We give back, change lives and offer unconditional support to the candidates we represent.
Put Connexion's 20 years of experience to work for you! Our professionals have unrivaled relationships and contacts with the hiring managers, human resources team and decision makers at the most desirable companies to work for.
Don't let your resume get lost in an inbox, Connexion's recruiting team will advocate on your behalf to get you the job you want
Skills
- Analysis Skillsunmatched
- British Standards Institute (BSI)unmatched
- Communication Skillsunmatched
- Corrective Actionunmatched
- Corrective and Preventative Action (CAPA) Systemsunmatched
- Cost Controlunmatched
- Cross-Functionalunmatched
- Documentation Reviewunmatched
- Electrical Componentsunmatched
- Electromagnetic Compatibilityunmatched
- Electromagnetic Interference (EMI)unmatched
- FDA (Food and Drug Administration)unmatched
- Federal Aviation Administration (FAA)unmatched
- ISO (International Organization for Standardization)unmatched
- Identify Issuesunmatched
- Insurance Regulationsunmatched
- International Electro-Technical Commission (IEC)unmatched
- Laboratory Equipmentunmatched
- Laboratory Testingunmatched
- Leadershipunmatched
- Lift/Move 40 Poundsunmatched
- Maintain Complianceunmatched
- Manufacturingunmatched
- Manufacturing Systemsunmatched
- Marketingunmatched
- Medical Equipmentunmatched
- Mentoringunmatched
- Microsoft Excelunmatched
- Microsoft Officeunmatched
- Microsoft PowerPointunmatched
- Microsoft Wordunmatched
- Multitaskingunmatched
- Operational Supportunmatched
- Oscilloscopeunmatched
- Physical Demandsunmatched
- Problem Solving Skillsunmatched
- Product Designunmatched
- Product Lifecycleunmatched
- Product Reviewsunmatched
- Product Testingunmatched
- Product/Service Launchunmatched
- Program Planningunmatched
- Project/Program Managementunmatched
- Python Programming/Scripting Languageunmatched
- Radio Frequency Identification (RFID)unmatched
- Regulationsunmatched
- Regulatory Complianceunmatched
- Requirements Managementunmatched
- Research & Development (R&D)unmatched
- Risk Analysisunmatched
- Risk Managementunmatched
- Safety Complianceunmatched
- Safety Standardsunmatched
- Source Code/Configuration Management (SCM)unmatched
- Spectrum Analyzersunmatched
- Team Lead/Managerunmatched
- Team Playerunmatched
- Test Equipmentunmatched
- Test Labunmatched
- Testingunmatched
- Training/Teachingunmatched
- United States Department of Defense (DoD)unmatched
- Vector Network Analyzersunmatched
- Verification Plansunmatched
- Wireless Communicationsunmatched
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