Siemens Careers

Sr. Manager - Reagent Control Project

East Walpole, Massachusetts

English (US)

Job Description

Division: Siemens Healthineers
Business Unit: Healthineers (HC)
Requisition Number: 224696
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%

Division Description:

Division Description
Siemens is a global technology powerhouse that has stood for engineering excellence, innovation, quality, reliability and internationality for more than 165 years. As a global technology company, Siemens is rigorously leveraging the advantages that this setup provides. To tap business opportunities in both new and established markets, the Company is organized in nine Divisions: Power and Gas, Wind Power and Renewables, Energy Management, Building Technologies, Mobility, Digital Factory, Process Industries and Drives, Healthineers and Financial Services.

With 45,000 employees Siemens Healthineers is one of the world’s largest suppliers of technology to the healthcare industry and a leader in medical imaging, laboratory diagnostics and healthcare IT. All supported by a comprehensive portfolio of clinical consulting, training, and services available across the globe and tailored to customers’ needs. So that more people can have a life that is longer, richer, and more filled with happiness.

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Job Description:

Sr. Manager Manufacturing:
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. 
  • Direct supervision and management of Control Systems Improvement team members.
  • Develop strategies, and plans to implement actions that will ensure success of on-time completion of Control Systems Improvement schedules and deliverables.
  • Facilitate 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.
  • Develop new processes as needed.
  • Actively track issues/projects/timelines.
  • Ensure alignment and integration with overall Control System Improvement strategy and deliverables.
  • Communicate status of issues/projects on a regular basis to all levels of the organization.
Desired Skills
  • 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.
Position Requirements
  • 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 IVDD experience in a technical role.
  • Master’s in related field preferred.
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.

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.

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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.