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Program Manager, IVD Device Development remote

Remote: 
Full Remote
Contract: 
Salary: 
105 - 140K yearly
Experience: 
Mid-level (2-5 years)
Work from: 
Ohio (USA), United States

Offer summary

Qualifications:

Bachelor’s degree in Life-Sciences or Engineering required, 5+ years of project management experience, Experience with IVD instruments preferred, Knowledge of FDA, ISO, IVDD regulations desired, Experience in clinical trials preferred.

Key responsabilities:

  • Lead subsystem workstreams for product development
  • Coordinate cross-functional aspects and resource needs
  • Support creation of material spend plans and monitor budgets
  • Collaborate to update technical risk-registers
  • Communicate project status to stakeholders
Siemens Healthineers logo
Siemens Healthineers Health Care Large https://siemens-healthineers.com/
10001 Employees
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Job description

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Your missions

Program Manager, IVD Device Development

Now’s our time to inspire the future of healthcare together.

Siemens Healthineers is a leading global medical technology company with over 170 years of experience and 18,000 patents. More than 48,000 dedicated colleagues in over 70 countries are driven to shape the future of healthcare. We stand with our customers around the world to support them in delivering high quality care to their patients. An estimated five million patients across the globe benefit every day from our innovative technologies and services in the areas of diagnostic and therapeutic imaging, laboratory diagnostics and molecular medicine, as well as digital health and enterprise services. This is what truly matters to us.

The Point-of-Care (POC) business develops and sustains systems for in vitro diagnostic (IVD) instruments for point of care and laboratory medical testing. Join our team now at Siemens Healthineers as the Program Manager IVD Devices. This individual contributor position is part of the POC PMO team and reports to the Sr. Director of PMO. The successful candidate will work closely with and under the guidance of Senior Program Manager on the next generation IVD Device Platform project. The successful candidate will support and influence a cross-functional program team to deliver stand-alone programs and projects critical to the strategy of the POC business at Siemens Healthineers.

This role will be responsible for supporting platform level initiatives and leading subsystem workstreams on new product development activities required for commercial launch.

  • Lead subsystem workstreams and coordinate cross-functional aspects of product development execution to help launch program/projects on time, at cost and with quality while adhering to Siemens Healthineers’ Product Development Process (PDP).
  • Lead subsystem level project planning including the incorporation of cross-functional plans, identification of the Critical Path resulting in a robust execution plan for all programs/projects.
  • Lead subsystem level bottoms-up identification of resource needs within programs/projects and collaboration with the relevant functional managers to ensure resource allocation matches the prioritized needs.
  • Support creation of bottoms-up direct material spend plan and monitor workstream budgets.
  • Collaborate with the technical leaders to ensure that technical risk-register is current, and the mitigation of technical risks is realistic. In addition, own and lead the mitigation of cross-functional risks.
  • Support communications to stakeholders, including project status and updates to management.

This position may suit you best if you are familiar with what is below, and would like to do develop your career with Healthineers:

  • You have strong leadership abilities to manage and lead teams in a matrixed organization
  • You can coordinate across disciplines and synthesize their input into a coherent plan.
  • You can constructively resolve challenges in an inclusive, data-driven way with “optimal program delivery” as the driving factor
  • You demonstrate poise and authority even in those areas without expertise while appropriately leveraging experts for their knowledge.
  • You have strong analytical skills to assess situations, identify insights and drive decision making and accountability
  • You have strong communication skills (written/verbal) and can adapt your style to match diverse audience and their disparate needs.You foster a culture of inclusion by encouraging the teams to speak-up and ensure psychological safety to ensure issues are identified and addressed at the earliest.

Required education, experience & skills:

  • Bachelor’s degree in Life-Sciences, Engineering or equivalent experience is required.
  • ­5+ years of experience in project management and product development related to medical devices is required; experience with IVD instruments, assay development is preferred.
  • Demonstrated experience in clinical trials in tandem with an in-house Clinical Affairs team or through external CRO in the management and execution of clinical trials is preferred and would be a differentiator.
  • Working knowledge of agile product development, FDA, ISO, IVDD and IVDR regulations desired
  • Demonstrated ability to lead diverse teams in a global matrix structure with superior influencing skills, change management and coordination

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

If you want to join us in transforming the way healthcare is delivered, visit our career site at https://usa.healthcare.siemens.com/careers

If you wish to find out more about the specific before applying, please visit https://usa.healthcare.siemens.com/about.

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities

At Siemens Healthineers, we value those who dedicate their energy and passion to a greater cause. Our people make us unique as an employer in the med-tech industry. What unites and motivates our global team is the inspiration of our common purpose: To innovate for healthcare, building on our remarkable legacy of pioneering ideas that translate into even better healthcare products and services. We recognize that taking ownership of our work allows both us and the company to grow. We offer you a flexible and dynamic environment and the space to move beyond your comfort zone to grow both personally and professionally.

The pay range for this position is $105,000-$140,000 annually; however, base pay offered may vary depending on job-related knowledge, skills, and experience. The annual incentive target is 8 % of base pay. Siemens Healthineers offers a variety of health and wellness benefits including paid time off and holiday pay. Details regarding our benefits can be found here: https://benefitsatshs.com/index.html. This information is provided per the required state Equal Pay Act. Base pay information is based on market location. Applicants should apply via Siemens Healthineers external or internal careers site.

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“Successful candidate must be able to work with controlled technology in accordance with US export control law.” “It is Siemens Healthineers’ policy to comply fully and completely with all United States export control laws and regulations, including those implemented by the Department of Commerce through the Export Administration Regulations (EAR), by the Department of State through the International Traffic in Arms Regulations (ITAR), and by the Treasury Department through the Office of Foreign Assets Control (OFAC) sanctions regulations.”

Equal Employment Opportunity Statement

Siemens is an Equal Opportunity and Affirmative Action Employer encouraging diversity in the workplace. All qualified applicants will receive consideration for employment without regard to their race, color, creed, religion, national origin, citizenship status, ancestry, sex, age, physical or mental disability unrelated to ability, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, order of protection status, protected veteran or military status, or an unfavorable discharge from military service, and other categories protected by federal, state or local law.

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Required profile

Experience

Level of experience: Mid-level (2-5 years)
Industry :
Health Care
Spoken language(s):
Check out the description to know which languages are mandatory.

Soft Skills

  • Verbal Communication Skills
  • Analytical Skills
  • Leadership

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