דרושים Avs Supply Chain Program Manager ב-Ge Healthcare ב-Denmark

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.

Job Description:

We are seeking a highly skilled Engineering Technology Project Manager to manage the engineering aspects of production transfer and product maintenance projects within our ultrasound scanner systems domain. This role is vital for interfacing with internal and external stakeholders, allocating resources to meet project requirements, and applying technical knowledge and experience, particularly in production transfer. The successful candidate will propose solutions, solve problems, guide new team members, and potentially lead a small team.

Key Responsibilities:

• Manage the engineering aspects of production transfer projects within the overall program.
• To some degree manage product maintenance projects
• Interface with internal and external stakeholders.
• Allocate resources to meet project requirements.
• Apply technical knowledge and experience, especially in production transfer.
• Analyse and resolve problems, propose solutions and to some extent complete straightforward tasks using technical skills and analytic thinking.
• Guide new team members and potentially lead a small team.

Qualifications:

• Bachelor´s degree or comparable to bachelor's degree in Biomedical Engineering, Mechanical Engineering, Electrical Engineering or similar.
• Proficiency in English oral and written
• Proven experience with Lean Six Sigma and / or Lean Manufacturing
• Strong experience in Engineering, Technology & Production Support. Preferably within the medical device industry or a similar regulated industry.
• Strong problem-solving and analytical skills.
• Excellent communication and teamwork abilities.
• Ability to work effectively with diverse teams and stakeholders.
• Ability to travel as required
• Required to be on-site in Denmark with ability to work from home as agreed with manager.

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 pay 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.

GE HealthCare prohibits the requirement for medical certification of non-pregnancy and Human Immunodeficiency Virus (HIV) status as requirements for admission, retention, or promotion.

Key Responsibilities:

• Oversee the application and integration of clinical products within healthcare settings.
• Collaborate with healthcare professionals to understand their needs and provide solutions.
• Monitor product performance and gather feedback for continuous improvement.
• Work closely with the product development team to ensure clinical products meet regulatory standards and user requirements.
• Provide clinical inputs in the product development of ultrasound solutions.
• Collaborate with various departments, including R&D, marketing, sales, and regulatory affairs, to ensure cohesive product development and successful market introduction.
• Adapt to changing timelines and priorities in an agile work environment, ensuring flexibility and responsiveness to project needs.
• Gather and incorporate clinical inputs from healthcare providers and patients to ensure ultrasound solutions are user-friendly and meet clinical needs.

Required Qualifications and Skills:

• Bachelor's degree in a relevant field (e.g., Healthcare, Biomedical Engineering, Clinical Research).
• Strong understanding of healthcare systems and clinical workflows.
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficiency in using clinical software and applications.
• Problem-solving skills and attention to detail.
• Experience with ultrasound solutions in a clinical setting.

Preferred Experience:

• Experience in clinical product management or a similar role.
• Experience in training healthcare professionals on clinical products.
• Knowledge of regulatory requirements for clinical products.
• Familiarity with product lifecycle management.
• Experience as an application specialist, providing technical and clinical support during the sales process, training customers, and ensuring optimal use of ultrasound equipment.

Additional Requirements:

• Willingness to travel as needed.

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.

• Lead the execution of interdependent deliverables across all functions represented on the Program Core Team, ensuring seamless program execution.

• Collaborate with the Program Manager to manage program resource and budget allocation/integration, overseeing schedule, budget, and tollgate processes for NPI.

• Understand key business drivers to accomplish own work. Have a good understanding of how own work integrates with other teams and how these contributes positively to a seamless program execution.

• Possess autonomy and good judgement to make decisions within a defined framework. If outside defined framework, ensure to consult senior team members for further instructions.

• Maintain regular communication with stakeholders to provide updates on program progress and address any concerns promptly.

• In collaboration with Director of PMO, drive continuous improvement initiatives within the Program Management Office by analyzing existing program processes and recommending and implementing enhancements.

• Hold a B.Sc. or M.Sc. in Engineering.

• 3-5 years of experience in project/program management and project planning, focusing on program execution.

• Proven experience in a project/program management or PMO role, with a successful track record of managing projects or processes and implementing best practices to enhance program execution efficiency.

• Proficiency in Advanced Excel and Microsoft Project (or similar) will be considered an advantage for this position.

• The candidate must be available to work on premise in Herlev.

• Possess strong collaboration skills to foster teamwork and build relationships, along with excellent interpersonal skills to create trustful relations with internal stakeholders, crucial for effective program execution.

• Exhibit good communication skills and proficiency in conveying complex ideas clearly.

• Demonstrate solid analytical skills and a self-driven approach, allowing for independent and efficient work.

• Some level of entrepreneurial skills needed to “show the way” and be the “lighthouse” that guides others, emphasizing leadership in program execution.

• A “get the job done” attitude with feet on the ground.

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.

Project Planning & execution

• Develop and manage comprehensive project plans for supplier transfers including timelines, budgets, and resource allocations.

• Define project scope, objectives, and deliverables in alignment with business goal.

• Coordinate cross-functional teams including sourcing, engineering, quality, operations, and QARA.

• Monitor and track project progress, identifying and mitigating risks and issues throughout the lifecycle of the program.

• Lead regular project meetings, reporting status and providing regular updates to stakeholders and leadership teams.

• Ensure compliance to GEHC QMS and industry standards.

• Work closely with suppliers to ensure smooth transition, including knowledge transfer, validation and capability/ readiness assessments.

• Developing in-depth knowledge of a discipline. Uses prior experience and acquired expertise to execute functional policy/strategy.

• Identify risks associated with supplier transfers and develop mitigation strategies with the program team.

• Ensure adherence to regulatory requirements including GEHC QMS standards and international medical device regulations and quality standards (ISO 13485, FDA 21 CFR Part 820, EU MDR, China NMPA, Japan PMDA) and other industry best practices.

• Conduct risk assessments (DFMEA, PFMEA) and implement contingency plans to prevent disruptions/ impacts to the program’s deliverables.

• Work with regulatory and quality teams to maintain documentation and approvals required for compliance.

• Manage project budgets, ensuring cost efficiency while meeting performance goals.

• Optimize supply chain strategies to reduce costs, improve efficiency and maintain product quality.

• Track supplier performance post-transfer/implementation, identifying corrective actions if necessary to ensure long-term supplier sustainability.

• Utilizes technical expertise and judgement to solve problems. Leverages technical skills and analytic thinking required to solve problems. May use multiple internal sources outside of own team to arrive at decisions.

• Bachelor’s degree in Engineering, Supply Chain, Business Management or related field.

• 8+ years of project management experience in supplier transfer, supply chain or manufacturing, preferably in the medical device industry.

• Experience managing global program teams and working across different time zones, cultures and regulatory landscapes.

• Experience in regulated industries such as medical devices, pharmaceuticals, aerospace, automotive.

• Strong knowledge of medical device manufacturing processes, validation and quality systems.

• Strong project management skills with experience in tools like MS Project and/or Smartsheet.

• Knowledge of supplier qualifications, validations and risk management.

• Strong problem-solving, negotiation and communication skills with the ability to work effectively across different cultures and time zones.

• Ability to manage multiple programs in parallel.

• PMP, Six Sigma, and/or Lean Manufacturing certification is a plus.

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.