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Project Manager 4 - Control System Sustainability

Job Description

Do you want to join us in helping to fight the world’s most threatening diseases and enabling access to care for more people around the world? At Siemens Healthineers, we pioneer breakthroughs in healthcare.  For everyone. Everywhere.

 

We offer you a flexible and dynamic environment with opportunities to go beyond your comfort zone in order to grow personally and professionally. Sound interesting? Then come and join our global team as a Project Manager 4.  This position will work closely with all levels of the organization in Walpole Operations (including manufacturing, supply chain and QC), R&D, Quality, Marketing, Medical Affairs, Labeling and Customer Support to successfully manage assay improvement, control system improvement, and critical raw material implementation change projects for commercialized products.

 

Our global team: We are a team of 66,000 highly dedicated employees across more than 70 countries passionately pushing the boundaries of what’s possible in healthcare to help improve people’s lives around the world. As a leader in the industry, we aspire to create better outcomes and experiences for patients no matter where they live or what health issues they are facing. Our portfolio, spanning from in-vitro and in-vivo diagnostics to image-guided therapy and innovative cancer care, is crucial for clinical decision-making and treatment pathways.

 

Our culture: We are part of an incredible community of scientists, clinicians, developers, researchers, professionals, and skilled specialists pushing the boundaries of what’s possible, to improve people’s lives around the world.  We embrace a culture of inclusivity in which the power and potential of every individual can be unleashed. We spark ideas that lead to positive impact and continued success. Check our Careers Site at https://www.siemens-healthineers.com/en-us/careers

This is a role well suited to an ambitious professional, looking for the next step in their career. As a Project Manager 4 supporting the Control System Sustainability (CSS) R&D team, you will be responsible for:

  • Forming and leading change project teams for projects initiated within Walpole CSS based on Centaur/Atellica Systems Immunoassay business needs
  • Creating project schedules, meeting minutes, presentations
  • Providing periodic updates on projects to different levels of management, including PHT
  • Drafting/coordinating of Design History File documentation, Device Master Record documentation, and project implementation-associated documentation, gathering input from cross-functional team, routing documents for approval (eg. RTMs, dFMEAs and other risk files, Design Verification Plans and Reports, ECOs for manufacturing documents (and redlines) BOMs, routings, design and process change documentation (CIAs, initial risk assessments, regulatory assessments, design change plans), labeling including customer bulletins and IFU changes)
  • Scheduling and monitoring feasibility, characterization and verification batches, working closely with the planning organization, including attending manufacturing/planning scheduling meetings
  • Providing strategic oversight to projects to ensure business objectives are met
  • Organizing reviews for protocols, reports, pFMEAs; Ensure deliverables are tracked/measured and reported on
  • Identify needed decisions and provide support to drive the decision-making process

Required skills to have for the success of this role

  • Bachelor’s Degree in Biochemical Engineering, Chemical Engineering, Biochemistry or Chemistry preferred, however, other disciplines may be considered for candidates with greater than 5 years of project management experience in clinical diagnostics or pharmaceutical product manufacturing. 
  • Five or more years’ experience with ADVIA Centaur, Atellica, or other immunoassays
  • Mid-level project management skills
  • Working knowledge of design control, change control, design and process change, risk management
  • Ability to travel up to 10%

Preferred Knowledge/Skills, Education, and Experience:

  • Strong knowledge in biology, immunology, and/or biochemistry
  • PMP certification or degree preferred
  • Strong understanding of Design Input Requirements, RTM Specification setting, Design Verification requirements and dFMEAs
  • Experience with implementation of complex design changes that impact customers and strong ability to plan/coordinate milestones assuring smooth transitions for internal groups (eg. Manufacturing and QC), regulatory requirements (eg. Filings) and customers (eg. letters, bulletins, field actions)
  • Familiarity with safety aspects of bio-hazardous materials and provide technical support for regulatory submissions/registrations and be experienced in risk management practices
  • Recent experience on cross-functional project teams
  • Ability to motivate, negotiate, resolve conflicts, advocate for projects at all levels of the organization

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.  Accommodations may be requested for certain medical or religious reasons.  If you choose to submit an accommodation request it should be submitted within 3 business days of receiving a verbal offer.  Details on how to submit approval will be provided by your recruiter.  An accommodation approval must be confirmed prior to your start date.  A start date cannot be confirmed until the accommodation has been reviewed.  An accommodation is based on your role.  If you are a currently a Siemens Healthineers employee with an existing approved accommodation, it will need to be re-evaluated prior to starting a new 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 

As an equal-opportunity employer we are happy to consider applications from individuals with disabilities. Why you’ll love working for Siemens Healthineers

  • Be part of exciting and innovative projects that help solve some of the world’s most significant health problems.
  • Engaging, challenging, and fast evolving, cutting edge technological environment.
  • Opportunities to advance your career.
  • Competitive total rewards package.
  • Contribute to our social responsibility initiatives focused on access to education and technology, and sustainability, making a positive impact on communities.
  • Participate in our celebrations and social events.
  • Opportunities to contribute your innovative ideas and get paid for them!
  • Employee perks and discounts.

We are globally recognized as an Employer of Choice, but don’t just take our word for it. Here are some of our most recent awards and recognition:

  • Great Place to Work Certified 2021
  • Best Places to Work for LGBTQ Equality
  • Best for Vets Employers by Military Times
  • Glassdoor Employer Rating: 4.0

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Organization: Siemens Healthineers

Company: Siemens Healthcare Diagnostics Inc.

Experience Level: Experienced Professional

Job Type: Full-time



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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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