|| E-mail this position|
|Job Requisition #:||NMD3216|
|Category:|| Electrical Engineering \
|Location:||Dallas - TX - USA
|Our teams produce game-changing ideas and life-changing results. A career at St. Jude Medical puts you on the leading edge of medical technology, working for a company driven by its entrepreneurial culture and its passion for quality. Isn't this the kind of change you would like in your life? We are an Equal Opportunity/Affirmative Action Employer. We currently have this position open in our Neuromodulation Division:|
|The Senior Compliance Engineer is responsible for minimizing risk to the organization associated with product design and realization efforts and ensures robust medical device product designs under governing domestic and international requirements. This position ensures and helps maintain Compliance vigilance across the R&D organization in compliance with applicable ISO, AAMI, EN, FDA, FCC, CSA standards and serves as the focal point for defining Compliance activities within the R&D organization. This position helps define, interpret, and/or ensure the use of, and compliance to, appropriate test standards and regulatory requirements that apply to R&D.
The successful candidate must possess:
• A strong desire and ability to personify the St. Jude Medical Credo and work as a role model
Excellent communication and interpersonal skills
• Strong technical skills, including analytical and problem solving skills
• Skills to execute technical project tasks and delivery of milestones consistently with a customer focused mindset
• Ability to stay current on engineering technologies, with emphasis on the neuromodulation field
• Ability to provides technical guidance and mentorship to junior engineering personnel
• Ability to take initiative and be innovative.
Major, On-Going Responsibilities:
• Represent Electrical Engineering group on Standards Council by:
-evaluating standards for product development, market expansions, and recertification activities,
-ongoing support to create/revise/maintain product standards-related processes and tools,
-maintain a high level of standards expertise within EE group,
-provide standards-related support for project core EE members.
- conduct/organize cross-functional training on domestic and international medical device standards.
• Insure standards compliance through cross-functional collaboration on product requirements specs, essential requirements reports, verification test plans/protocols/reports, FMECA reports, and risk analysis reports.
• Participate in reviews of designs and design documentation to ensure that all domestic and international engineering practices, laws and regulations are being met consistently.
• Collaborate with Regulatory group on regulatory submissions/reviews with respect to standards compliance.
• Support Quality group during internal/external audits with respect to standards compliance.
• Collaborate with other St. Jude Medical business branches with respect to existing and emerging compliance activities, including industry standards, mandates and recommendations (AIMD, environmental, safety, EMC, labeling, harmonized and normative standards).
Experience & Training:
• Bachelors degree in Electrical Engineering
• Minimum 5 years related work experience in product development, quality assurance, quality engineering or regulatory affairs.
• Strong knowledge and experience in tracking with domestic and international medical and commercial device directives (such as with the AIMD, MDD, R&TTE, EMC Directive, Low Voltage Directive, etc.).
• Product EMC and safety experience and familiarity with EN, IEC, CSA, ISO, FCC and other relevant domestic and international standards,
Proofs of successful involvement in two or more complex projects from concept to production release, Experience in a highly regulated development environment, especially in FDA.
• Familiarity with FDA consensus standards.
• Experience participating in FDA/TUV/CSA/UL audits.
|| E-mail this position|
|Submit Resume or C.V.|