Lead Compliance Engineer, R&D
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Overview
Remote
On-site
Compensation
$140-$160/hour
Job Description
Job Title: Lead Compliance Engineer, R&DSalary: Mid-point and target $140-$160 absolute MAX + 12% bonusLocation: WilmingtonDuration: PERMShift: M-F 1st shift, flexible start timesKey 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.
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FAQs About Lead Compliance Engineer, R&D Jobs at Connexion Systems + Engineering
What is the work location for this position at Connexion Systems + Engineering?
This job at Connexion Systems + Engineering is located in Wilmington, DE, according to the details provided by the employer. Some roles may also include multiple work locations depending on the requirement.
What pay range can candidates expect for this role at Connexion Systems + Engineering?
Candidates can expect a pay range of $140–$160 per hour for this role.
What employment applies to this position at Connexion Systems + Engineering?
The employer has not provided this information. This may be discussed during the hiring process.
What is the process to apply for this position at Connexion Systems + Engineering?
You can apply for this role at Connexion Systems + Engineering either through Sonara's automated application system, which helps you submit applications 10X faster with minimal effort, or by applying manually using the direct link on the job page.