The Compliance Engineer II primary responsibility is to provide support for all product compliance related tasks are completed by the scheduled dates and maintained over the products lifetime. This includes product safety and EMC testing, technical files and related documentation, DHF’s, DoC’s, product marking and associated regulatory duties.
This person works within the Compliance Engineering group and with members within the Instrument Development Group, (IDG). In addition, the position provides cross functional participation and support with QA, NPI, Marketing, Operations, Global Service Support - (GSS), Regulatory Affairs and management at all levels.
The successful candidate will be versed with international product compliance regulations (EU Directives, FCC, NRTL, and QMS) and have hands-on experience with EMC, safety, risk management evaluations. Common EU Directives and standards include; LVD, EMCD, IVDD, MD, RoHS, EN ISO 14971, IEC 61010, ASME, IEC 61010, IEC 61326, IEC 61000-4-x, ISO 13485 and related standards.
- Assist with the execute compliance EMC, (radiated / immunity) and safety test plans and testing for new and existing internal and external product evaluations.
- Participate in the creation and maintenance of Technical Files, DHF’s, RM Files, DoC’s and department procedures and test methods.
- Support the creation of Compliance Plans and Summary Reports.
- Assist with ECR evaluations that may affect product compliance through research and testing.
- Assist with monitoring worldwide regulatory regulation and standards.
- Assist with both internal and external process and procedural audits.
- Assist representing Compliance Engineering IDG during risk management assessments to provide evaluation consistency.
- Support Regulatory Affairs with international IVD product submissions.
- A minimum of 3 years of related work experience is required.
- Demonstrated competency of product safety, (IEC 61010) and EMC, (IEC 61326) with hands-on problem solving is preferred.
- Demonstrated competency of regulatory requirements including EU Directives, IVD medical device regulations, RM ISO 14971, FDA QSR’s, QMS ISO 13485 and regulatory audits.
- An understanding of Design History Files, (DHF), and Design Master Records, (DMR) requirements and processes.
- Excellent communication skills, both written and verbal.
- Proficient is MS Office 360, (Word, Excel, Visio, and PowerPoint) and SAP.
- Ability to travel (domestic or international).
- Database development experience preferred.