USA - Sr. Principal Engineer (1017064)
Click the Facebook, Google+ or LinkedIn icons to share this job with your friends or contacts. Click the Twitter icon to tweet this job to your followers. Click the link button to view the URL of the job, which then can be copied and pasted into an e-mail or other document.
Round Lake, IL 60073
Job Title: Compliance Engineer
(Medical Device Risk-Subject Matter Expert)
This professional will be responsible for leading the efforts in the coordination and management of standards compliance activities for assigned programs. This includes working with cross-functional product development partners to identify requirements, develop and execute compliance plans, coordinate testing activities, review compliance testing results and partner with certification agencies to certify products. This position requires candidates to maintain their knowledge of current standards and developing or changing standards that affect our client’s products.
Some of the activities will include:
• Partner with design engineers to develop product requirements to comply with standards and regulations for intended use markets, develop Compliance Plans, participate in design and development activities and partner to resolve product certification, compliance and safety issues.
• Consult with program teams on product certification strategy and compliance issues where needed
• Will work under the direction of the Product Certification and Labs Engineering Manager to ensure compliance of hardware solutions with standards requirements. Will also support efforts to comply with environmental regulations.
• Facilitate and coordinate input from multiple cross-functional partners including program management, R&D teams, manufacturing sites and service locations to: develop comprehensive product certification and compliance strategies, develop and maintain therapy area compliance roadmaps and dashboards, and ensure that client solutions comply with product certification requirements in the intended use markets (domestic and international).
• Keep abreast of changes to product standards and regulations affecting medical products.
• Periodic travel will be required to perform job duties.
• Ensure that all compliance test equipment complies with the test requirements specified in compliance standards.
• Schedule compliance testing for client products at onsite test facility and at external test laboratories. Manage product test and certification projects with onsite and external test laboratories.
• Ensure compliance test equipment is well maintained and calibrated in accordance with international requirements.
• Submit documentation to regulatory authorities as required to obtain product certifications (e.g. EU, UL, Canada, Korea, Japan, Australia/New Zealand)
• Develop standards strategy for client programs that enable market access of medical devices in the intended markets for products
Responsibilities and Duties
• Plan and execute product certification program commitments including supervision and oversight of testing at on-site and off-site test facilities.
• Keep abreast of changes to regulations impacting Radio Sensitive Device products through reading trade periodicals, attending conferences, searching the internet and networking within the standards community.
• Prepare product qualification submittal documentation to regulatory agencies
• Ensure that lab test procedures and compliance process process comply with client policies, and international standards and quality management requirements.
• Support organizations located throughout the world in their efforts to obtain product certifications approvals
• Prepare standards test reports and other documentation in accordance with applicable regulations.
• BS or MS in electrical engineering with 10 or more years experience in the design and implementation of complex embedded software systems.
5 or more years of experience in compliance engineering on complex design projects utilizing formal standards testing methodologies.
• Knowledge of medical device requirements for European Union, Canadian, Australian, INMETRO and UL standards.
• Knowledge of EMC phenomenon in Medical Equipment
Excellent understanding of EMC test equipment and testing method in accordance with domestic and international standards
• Knowledge of EMC regulations and certification procedures applicable to Medical Devices sold worldwide including testing documentation, certification requirements and procedures (i.e. EN14971, EN60601, CISPR 11, FCC, EU etc.).
• Ability to perform diagnostics and correct EMC failures in conjunction with design engineers
• Strong electronics background is essential
• Strong experience in Requirements Management, Configuration Management, Defect Tracking and Traceability
• Experience with EMC design tools, automated EMC testing tools, electronic test equipment (scopes, logic analyzers)
• Strong team player, able to meet deadlines and handle changing priorities
• Good hardware interfacing background and extensive system integration experience with microprocessor hardware and software.
• Experience in resolving complex technical problems using strong analytical skills
• Excellent written, oral and interpersonal skills
• Must be proficient at time management and multitasking
• Knowledge of FDA’s guidance on design controls and software validation, as well as ANSI/IEEE standards for EMC engineering
• Demonstrated experience interfacing with regulatory agencies, conformity assessment bodies (UL, Intertek, CSA, etc.) and standards development organizations (IEC, ISO, NEMA, NFPA, ETSI, etc.).
Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at firstname.lastname@example.org or 844-463-6178.
VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.