8 - 10 years
Posted 266 days ago
Senior Manager of Engineering
Competitive compensation package; base, bonus, lucrative benefits
We have an immediate need for an experienced Senior Manager of Compliance for a medical device manufacturer (global Fortune 100). This is a very high level position within the department, and you will work with all stages of product development life-cycle ensuring compliance for EMC/Safety Standards and FDA/European regulatory documents. You'll partner withEngineering, Quality, Regulatory, and other groups across the organization. This role requires high level of skill, understanding "state of the art" requirements, newly released compliance standards, user workflow, functionality. The products that come out of this group are highly complex, dynamic, and ever-changing. The Senior Manager will supervise, prioritize and coordinate daily activities of the ISO accredited laboratory (EMC and Safety). This role requires skill of juggling multiple projects in different phases, as well as balancing priorities and schedule commitments. It coordinates activities across multiple sites and with 3rd party testing laboratories (UL, Intertek, TUV, etc).
? Manage technical regulatory compliance; research, methodology, planning, testing, and record management for Product Safety, EMC, Machinery, Wireless, etc. Principal standards include but not limited to IEC/EN/UL 61010-1, IEC 61010-2-x, IEC 61326-2-6, FCC Part 15, IEEE 802.11; EU Directives IVD, MD, RoHS; IECEE CB Scheme certificates
? Possess sharp decision-making capability in regulatory compliance with strong expertise of domestic and international regulatory compliance requirements (e.g. FDA QSR and ISO/EN standards).
? Manage a team that is responsible to perform EMC and product safety testing, coordination with testing labs, compliance verification, trouble shooting, report writing, and review of all ECO's.
? Maintain ISO17025 accredited EMC & Safety Client Test Lab with the capability to conduct 5m Semi-anechoic Radiated Emissions/Immunity, EFT, ESD, Surge, Acoustic Noise, and 61010-1 Safety measurements. Ensure lab quality procedures and calibrated test equipment are accurate and current.
? Act as the point person for agency interactions (UL, Intertek, TUV, IEC TC?s) including preparation of test packages and strategy for meetings, inspections, advisory committee meetings, and responses to test agency letters.
? Evaluate manufacturing changes for regulatory impact and to ensure compliance with applicable regulations.
? Bachelor's Degree in Engineering, Technology, Science, or Similar. Advanced Degreedesired not required.
? 8-20+ years experience in Compliance, abiding by EMC/Safety Standards.
? Knowledge of CISPR 11 & 16, IEC/EN 61326-2-6, IECEN 61326-1, IEC/EN 61010-X and ISO17025. Experience with ISO14971Risk Management is a plus.
? Experience conducting hands-on testing of: mechanical and electrical safety, and EMC emissions, and immunity with the ability to interpret results and troubleshoot test setups. Must have proven problem solving, analytical, and logical reasoning skills.
? Excellent written and oral communication skills, strong work ethic, detail oriented and be self-motivated, with the ability to learn quickly and independently as well as work well within a team.