Manager, IVD Control Systems Improvement & Sustainability

Job Description

Organization: Siemens Healthineers
Business Unit: Diagnostics
Requisition Number: 245722
Primary Location: United States-Massachusetts-East Walpole
Assignment Category: Full-time regular
Experience Level: Senior level
Education Required Level: Bachelor's Degree
Travel Required: 5%

Job Description:

At Siemens Healthineers, we are passionate about enabling healthcare professionals to deliver high quality patient care, and to do so affordably.  A leading global healthcare company, Siemens Healthineers continues to strengthen our portfolio of medical imaging and laboratory diagnostics, while adding new offerings such as managed services, consulting, and healthcare IT services – as well as further technologies in the growing market for therapeutic and molecular diagnostics.

Siemens Healthineers develops innovations that support better patient outcomes with greater efficiencies, giving providers the confidence they need to meet the clinical, operational and financial challenges of a changing healthcare landscape.

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 5 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.


Join our team now at Siemens Healthineers as a Manager, IVD Control Systems Improvement & Sustainability.


Key Management and Leadership role in Design Quality Systems, focused on Control Systems Improvement. 

 

The incumbent of this position will lead and provide managerial support and technical guidance to a team focused on developing standardization strategies for existing products.  This includes developing Anchor and Gold Standards and MDPs when not in existence.  In addition, this position will focus on modification to the value assignment process to align with new control system requirements.  The person will create protocols as well as carry out data analysis and write internal reports and documentation.  The person will work with serum and other biological fluids of human and animal origin. 

 

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Manager, IVD Control Systems Improvement & Sustainability, you will be responsible for

  • Direct supervision and management of Control Systems Improvement team members.
  • Developing strategies, and plans to implement actions that will ensure success of on-time completion of Control Systems Improvement schedules and deliverables.
  • Facilitating cross functional communication and collaboration across the organization in order to identify opportunities and eliminate obstacles.
  • Tactical and strategically plan ahead and identify challenges before they impact Control System Improvement deliverables.
  • Developing new processes as needed.
  • Actively tracking issues/projects/timelines.
  • Ensuring alignment and integration with overall Control System Improvement strategy and deliverables.
  • Communicating status of issues/projects on a regular basis to all levels of the organization.

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

  • Master’s in related field preferred.
  • Understanding of the assay architecture, design of immunoassays. Manufacturing experience a plus.
  • Experience in Design Control; including, Design Change, Process Change, Verification and Validation and Risk Management.
  • Good understanding of FDA and ISO regulations.
  • Demonstrated ability to analyze problems in a structured and systematic manner with the proven ability to interpret data and to troubleshoot and resolve technical issues.
  • Excellent quantitative skills and knowledge of statistics enabling the ability to work cross-functionally with statisticians.
  • Ability to multi-task and to support multiple project teams in cross functional settings.
  • Excellent organizational, oral and written communication skills.
  • Ability to write clear and concise plans and reports and other quality documents.
  • A natural ability to manage and develop a diverse team with varying skill sets.

Required skills to have for the success of this role

  • Minimum of a Bachelor’s degree in Chemistry, Biology or Biological Science.
  • 8+ years of successful experience in a directly related field with a demonstrated track record of success.
  • Minimum of five years previous management experience.
  • Experience working in a regulated industry (for example FDA)
  • Previous IVD experience in a technical role.

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.


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, marital status, family responsibilities, pregnancy, genetic information, sexual orientation, gender expression, gender identity, transgender, sex stereotyping, protected veteran or military status, and other categories protected by federal, state or local law.

EEO is the Law
Applicants and employees are protected under Federal law from discrimination. To learn more, Click here.

Pay Transparency Non-Discrimination Provision
Siemens follows Executive Order 11246, including the Pay Transparency Nondiscrimination Provision. To learn more, Click here.

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