Technical Regulations & Standards Leader – Ind. X-Ray (m/f)
- Job Function: Engineering/Technology
- Experience Level: Experienced
- Posted Date: 2/21/2018 11:53:25 AM
- Job #: 3047252
- Location(s): Germany; Ahrensburg near Hamburg or Wunstorf near Hannover
Baker Hughes, a GE company (NYSE:BHGE) is the world’s first and only fullstream provider of integrated oilfield products, services and digital solutions. Drawing on a storied heritage of invention, BHGE harnesses the passion and experience of its people to enhance productivity across the oil and gas value chain.
BHGE helps its customers acquire, transport and refine hydrocarbons more efficiently, productively and safely, with a smaller environmental footprint and at lower cost per barrel. Backed by the digital industrial strength of GE, the company deploys minds, machines and the cloud to break down silos and reduce waste and risk, applying breakthroughs from other industries to advance its own.
With operations in over 120 countries, the company’s global scale, local know-how and commitment to service infuse over a century of experience with the spirit of a startup – inventing smarter ways to bring energy to the world. Follow Baker Hughes, a GE company on Twitter @BHGECo, or visit us at BHGE.com.
This role will provide subject matter expertise to Engineering teams to ensure that all GE Inspection Technologies (GEIT) Radiography products are in compliance with technical regulations to ship to all regions during all phases throughout product lifecycle.
In the role of Technical Regulations and Standards (TR&S) Leader for industrial X-Ray products (m/f) responsibilities include, but are not limited to:
Product Compliance and modality expertise – The TR&S Leader will identify all product legislation that impacts Radiography products within their modality and drive compliance.
- NPI Projects – TR&S Leader will integrate with New Product Introduction (NPI) teams to ensure products are designed to meet TR&S requirements.
- Sustaining Projects – Support global TR&S team in getting product approvals for modality specific products to new legislation.
- SAP GTS – The TR&S Leader will be responsible create and maintain product licenses in the GTS tool.
- Documentation – TR&S Leader will work with design and sustaining teams to ensure product TR&S requirements traceability from product inception to product retirement.
- Compliance testing – Assist NPI team in specifying and performing product compliance testing for new and sustaining products.
- SAFER – TR&S Leader may be required to assist in the creation or maintenance of proactive or reactive SAFER cases that impact their modality.
- Update licenses in SAP to ensure that compliance checking is up to date, and TR&S blocks are properly applied.
- Bachelor’s Degree in Engineering or Technical degree from an accredited university or college or equivalent knowledge and experience
- Some experience working with Radiography principles and products, industrial or medical.
- Several years of experience working with global technical regulations.
- Willingness and ability to travel, as required.
- Experience working with Radiography products • Working knowledge of SAP, and GTS module for TR&S.
- Regulatory compliance knowledge, particularly Radiography regulations such as FDA 21 CFR 1020.40, EURATOM Directive, or other regional regulations.
- Working knowledge of EU legislation (ie. Machinery Directive, LVD, EMC, RED).
- Familiarity with radiation leakage measurement instruments & methods.
- Experience with GE Inspection Technologies products, or experience in the Oil and Gas industry would be an advantage.
- Working knowledge of M&C or O&G processes (e.g. NPI / ITO / OTR / Commissioning / Sourcing) would be an advantage.
- Trained Radiation Safety Officer.
Locations: Germany; Ahrensburg near Hamburg or Wunstorf near Hannover
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