דרושים ב-Ge Healthcare ב-Denmark

• Establish, maintain, and take ownership of the acoustic and thermal measurement laboratory in compliance with international standards such as ISO/IEC17025 and IEC60601-2-37.

• Manage calibration, procurement, and lifecycle of laboratory instruments and tools to ensure measurement accuracy and traceability.

• Oversee equipment qualification and ensure readiness for acoustic and thermal testing activities.

• Measure sound pressure, acoustic power, thermal characteristics, image performance, and other transducer properties.

• Control document changes and manage releases within the documentation system.

• Support internal and external audits, ensuring documentation and processes is compliant.

• An engineering degree or similar technical background.

• Theoretical and practical knowledge of measuring and test techniques and instruments, e.g., oscilloscopes, signal generators, data loggers, and temperature probes.

• Experience working in teams.

• Experience measuring acoustic and thermal parameters or other physical quantities.

• Experiences maintaining a laboratory under compliance with international standards for medical devices.

• Systematic and analytical approach to development processes, taking responsibility for tasks and seeking continuous improvement.

• Strong oral and written communication skills in English and Danish.

• Motivated, self-driven team player willing to share knowledge.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Work closely with project managers,R&D, marketing, and regulatory affairs teamsto understand requirements and deliver high-quality content that meets both internal and external needs.

• Create, update, review and deliver documentation and facilitate translations (e.g., user manuals and product datasheet)

• Coordinate, plan and update project status with other team members in Tech Docs

• Continuously and proactively work on optimizing your and the department skills within Technical writing

• Suggesting better ways of working and best practices

• Ensure documentation conforms to corporate standards and is translated accurately into multiple languages.

• Contribute to knowledge management initiatives by maintaining documentation templates and guidelines.

• Assist in defining workflows and processes for Technical writing Interpret and apply regulations, policies, and processes

• 5+ years’ work experience and proven track record as a technical writer within the medical device industry.

• Education as a (Technical writer, Technical editor, Engineer, or a linguist) is an advantage

• Excellent written and verbal communication skills in English.

• Proficiency in Microsoft Office Suite, particularly Word, PowerPoint, and Excel.

• Experience working with Content Management System tools such as Astoria or Tridion

• Familiarity with Adobe InDesign and Illustrator is a plus.

• Proactive approach and readiness to "hunt" for information

• Strong interpersonal, verbal communication, presentation skills and technical communication skills

• Experience working with global development sites

• Ability to work independently and collaboratively in a fast-paced environment with a strong problem-solving mindset.

• Experience managing documentation projects

• Proven ability to work independently and in teams

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Measure sound pressure, acoustic power, thermal characteristics, image performance, and other transducer properties. In compliance with international standards as in compliance with IEC 60601-2-37 and IEC 62359.

• Plan transducer integration tasks in cooperation with transducer project managers.

• Write and review test plans, protocols and measurement reports for product submissions to regulatory authorities.

• Maintain and improve existing procedures and tools.

• Assess the impact of new or updated standards and regulations (e.g., FDA, UL, ISO, MDR) on existing procedures.

• Support internal and external audits, ensuring laboratories, equipment, documentation and processes are compliant.

• An engineering degree or similar technical background.

• Experience with laboratory work aimed at regulatory approvals.

• Theoretical and practical knowledge of measuring and test techniques and instruments, e.g., oscilloscopes, signal generators, data loggers, and temperature probes.

• Ability to develop a comprehensive system overview and in-depth knowledge of complex systems like ultrasound scanners.

• Experience measuring acoustic and thermal parameters or other physical quantities.

• Systematic and analytical approach to development processes, taking responsibility for tasks and seeking continuous improvement.

• Experience with international standards for medical devices.

• Strong oral and written communication skills in English and Danish.

• Motivated, self-driven team player willing to share knowledge.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Roles and Responsibilities

• Lead and mentor a team of 6 engineers in the development and support of ultrasound products.
• Ensure adherence to Design Control processes in compliance with ISO 13485 and FDA 21 CFR Part 820.
• Drive larger tasks or cross-functional projects related to our area.
• Collaborate cross-functionally with QA, RA, Marketing, and the rest of Engineering.
• Support the team in audits, Design Control, and technical discussions.
• Be responsible for the DHF.
• Promote continuous improvement in engineering practices and documentation.
• In-depth understanding of key business drivers. In-depth understanding of how work of own team integrates with other teams and contributes to the area.
• Has access to technical skills and analytic thinking required to solve problems.

Required Qualifications

• Master’s degree in Engineering or a related field.
• Minimum 7 years of experience in the medical device industry.
• Strong knowledge of Design Control and regulatory requirements.
• At least 2 years of experience in a leadership role.
• Excellent communication, leadership, and problem-solving skills.
• Experience with project management tools and methodologies.

Desired Characteristics

• Strong oral and written communication skills.
• Ability to analyze and resolve problems.
• Ability to empower the team.
• Collaborative approach.

Our total rewards are designed to unlock your ambition by giving you the drive and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters caring, collaboration and support.

• Strategic planner and thinker with ability to drive change across the site

• Leading change through creative solutions to unstructured product and system design issues

• Provide strong functional leadership for the team, ensuring we have the right competencies in place, team/talent development, skill set improvement, and mentoring

• Resource assignment and prioritization including headcount and base cost budget

• Driving continuous improvement of systems, products, and processes

• Working internally to resolve business issues that require cross functional leadership and support

• Support existing products within Manufacturing, Sourcing, Service and Supplier Quality Engineering

• Drive compliance/closure of Regulatory and Quality requirements before approving design changes

• Build a continuous improvement culture where every team member is encouraged to identify and address improvement opportunities in their areas of expertise

• Interaction with adjacent functions as needed to solve issues.

• Interprets internal and external business challenges and recommends best practices to improve products, processes or services. Utilizes understanding of industry trends to inform decision making process

• Uses multiple internal and external resources outside of own function to help arrive at a decision.

• Strong leadership skills with the ability to inspire, develop, and retain top engineering talent

• Strategic mindset with a hands-on approach to operational excellence

• This role requires significant experience in the Engineering/Technology & Functional Management.

• Master's degree from an accredited university or college (or a high school diploma with at least 6 years of experience in Job Family Group(s)/Function(s)).Proven experience in leading large engineering teams, preferably in a complex or regulated industry

• Demonstrated engineering knowledge, program management, and business planning processes, having experience with the full product lifecycle

• Experience working cross-functionally with product development, quality, supply chain, commercial etc.

• Strong business acumen and the ability to influence at senior leadership level

• Experience and qualifications from the MedTech industry are highly desirable

• Understanding of regulated Healthcare industry

• Excellent communication skills in Danish and English

• The right candidate must reside in Denmark

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration, and support.

Responsibilities :

• Perform advanced troubleshooting and repair on assigned equipment.

• May also perform installation, validation and maintenance on assigned equipment.

• Lead, instruct, and assist less experienced Field Engineers and provide coaching and feedback to team members.

• Lead communications with customers and serve as escalation point for customer-related concerns including installs.

• Own customer issues from dispatch or identification of issue to resolution. Proactively engage with other team members to ensure they are aware of status of all issues at all times for their designated customers.

• Lead and communicate HQ and Zone or Area-level initiatives.

• Co-lead regular team or modality meetings as required.

• Partner with the customer and recommend value-added services that will help the customer run their business more efficiently.

• Keep up to date on administrative responsibilities such as maintaining customer service logs and internal service records in a timely manner, ordering repair parts, and managing cycle times.

• Utilize the GEHC escalation process, as needed, and work closely with region and national support to define and implement corrective action plans to resolve customer issues in a timely manner.

• Effectively communicate and partner with teammates and colleagues.

• Serve as a member of the account community for key accounts. Effectively engage commercial counterparts, identify potential sales leads, participate in sales opportunities such as contract renewals, and assist with promoting and implementing revenue programs.

• Embody the belief that Customers determine our success by focusing on customer needs and satisfaction, while building on and enhancing the relationship with the customer to ultimately become a perceived partner in their business.

• Keep up to date with competitor information and market trends.

• Demonstrate strong commercial acumen. Serve as a key member and leader of the account community for assigned accounts.

• Exhibit boundaryless collaboration with Commercial Sales teams and region/zone leadership to support business growth.

• Assist Area Service Manager or Director of Service in creating growth and/or deployment strategies.

• May include application training of clinical or scientific staff on designated equipment.

Qualifications :

• Associate's or Bachelor's degree in Electrical Engineering, Biomedical Engineering, Mechanical Engineering, or related field and 4+ years of experience servicing electrical equipment;

• OR equivalent military education and 4+ years of experience servicing electrical equipment;

• OR High School Diploma/GED and 8+ years of experience servicing electrical equipment.

• Experience interfacing with both internal team members and external customers as part of a solution based service process.

• Experience diagnosing and repairing mechanical, electromechanical, and/or electronic equipment.

• Experience troubleshooting and responding to customer concerns.

• Experience with Web applications as well as Microsoft suite of products.

• The successful applicant must comply with GEHC's standard background check, including a post-offer drug test.

• In addition, during employment, the employee must comply with all customer access policies, including but not limited to obtaining and/or providing proof of required immunizations, and additional drug tests or background checks (including a federal government background check if assigned to support a contract with the federal government).

• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

• Able to work 3rd shift.

Special Physical Requirements:

• Candidate must be able to lift, carry, push, and pull up to 35 lbs. unassisted and frequently bend, stoop, twist, climb, crouch/squat, kneel/crawl, sit and stand for long periods of time.

• Candidate must also be able to reach at, above and below shoulder level, flex/extend neck and have good hand and finger dexterity.

• Specific vision abilities required by this job may include color, close vision, distance vision, peripheral vision and depth perception.

• Willingness to be available ""after hours"", or work a rotating On-Call schedule, including weekends, for critical issues and coverage, as necessary.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

• Perform measurement of sound pressure, acoustic power, thermal characteristics, image performance, and other transducer properties.

• Plan and coordinate transducer integration tasks in cooperation with transducer project managers.

• Prepare and review measurement reports for product submissions to regulatory authorities.

• Maintain and improve existing procedures and tools.

• Ensure laboratory equipment is functional and calibrated according to requirements.

• Assess the impact of new or updated standards and regulations (e.g., FDA, UL, ISO, MDR) on existing procedures.

• An engineering degree or similar technical background.

• Experience with laboratory work related to regulatory approvals.

• Solid theoretical and practical knowledge of measuring and test techniques and instruments, e.g., oscilloscopes, signal generators, data loggers, and temperature probes.

• Experience working effectively in teams.

• Experience measuring acoustic and thermal parameters or other physical quantities.

• Experience documenting medical or other types of equipment governed by regulatory requirements.

• Fluent in English, both written and spoken.

• Strong analytical skills and attention to detail.

• Eager to learn new systems and improve processes.

• Motivated, self-driven, a team player, and willing to share knowledge

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.