Manager, Assay Development

Job Description

Manager, Assay 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 60,000 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 Manager within the Assay Development and Shared Scientific Services Organization.

The Manager, Assay Development is part of the dedicated Point of Care (POC) R&D Assay Development and Shared Scientific Services team and is responsible for leading product lifecycle management including support activities for in vitro diagnostics (IVD) instruments and consumables. The Shared Scientific Services team works closely with other functions within R&D including New Product Development, Service, Manufacturing, and Quality to investigate and drive corrective actions in response to field issues, resolve manufacturing obsolescence and manufacturing quality issues, lead design change projects aimed at improving product quality and reliability as well as cost reduction programs. This team is also responsible for the verification and validation activities throughout the product life cycle management process.

The successful candidate will bring balance to the role by being a technical expert, coach, and process leader. They will be responsible for having an aligned agenda for the team that will manage project execution, build team capabilities, and consistently achieve business goals.

Key Responsibilities:

  • Manage a cross-functional team of R&D Professionals
  • Develop team capabilities and capacity through coaching, training, and stretch assignments
  • Set mutual performance expectations with direct reports, monitor progress, recognize accomplishments, and support their development and project deliverables
  • Collaborate with peers in new product development to optimize processes and tools
  • Ability to multi-task and to support multiple project teams
  • Cultivate, maintain, and strengthen cross-functional relationships and networks within R&D, Manufacturing, Quality, Marketing and Service to achieve business targets
  • Support, drive timely closure for all escalated assay-related field complaints and manufacturing issues
  • Collaborate with Product Owners to regularly review resource needs and review team deliverables

Required Knowledge/Skills, Education, and Experience

  • BS in a Science or Engineering discipline with a minimum of 5 years of experience working in multi-disciplinary, cross-functional teams with project leadership and/or product lifecycle management responsibilities. Experience in sensing technologies preferred.
  • Strong fundamental scientific background
  • Excellent quantitative skills and demonstrated application of complex experimental and statistical methods
  • Skilled in systems thinking
  • Comfortable operating in a fast-paced, multi-functional organization with competing priorities
  • Experience in a regulated industry required to ensure alignment with regulatory expectations (FDA, IVDR)
  • Strong verbal, written communications, and interpersonal skills
  • Problem solving, attention to detail and follow-up
  • Experience with use of Agile methodologies
  • Must be a self-starter with strong analytical decision-making and multi-tasking capabilities to support multiple project teams
  • Experience coordinating and managing R&D teams to develop, execute and complete assignments for new and existing Point of Care products
  • Knowledgeable of, and adherence to Good Laboratory Practices, Quality Management System directives
  • Experience in facets of clinical science including professional technical writing for protocols and reports, including statistical analyses
  • Proficient in CLSI and ISO guidelines for Verification and Validation protocol design and execution
  • Proficient in Microsoft Word, Excel, PowerPoint, Minitab, Analyze-It

Siemens Healthineers has recently announced the next steps in our continued commitment to prioritize colleague health, comply with customer/business partner requirements, and help preserve our business continuity.  Going forward, please be aware that Siemens Healthineers requires full COVID-19 vaccination for all new hires by their start date except where prohibited by state law.

(Note: Accommodations may be requested for certain medical or religious reasons)

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

If you wish to find out more about the specific before applying, please visit:

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


Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time

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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