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Senior R&D Project Manager

Location: San Jose, CA, United States
Position Type: Unfixed Term
Job Function: Bioscience R&D

A family-owned company, bioMérieux has grown to become a world leader in the field of in vitro diagnostics. For almost 60 years and across the world, we have imagined and developed innovative diagnostics solutions to improve public health. Today, our teams are spread across 44 countries and serve 160 countries with the support of a large distribution network. This includes our SLC site, formerly known as BioFire Diagnostics.

Description

The Company

The world is facing a medical crisis, bacteria are increasingly evolving resistance to even our strongest antibiotics. The problem is already very real and immediate; for example, bloodstream infection leading to sepsis is now responsible for more than half of all deaths in hospitals and is the most expensive condition treated in hospitals. Sepsis mortality rate increases >6% every hour without effective antibiotic treatment. Yet, despite the life and death urgency, and healthcare cost impacts, current methodologies require 3 days to determine the correct antibiotic.

Specific Diagnostics has developed a breakthrough solution to rapidly determine the effective antibiotic treatment for bloodstream and other acute infections. Used for bloodstream infection Specific’s solution provides results 2 days sooner (1 day vs 3 days).

We offer an opportunity to join us at an inflection point in our commercial growth, with our first commercial product being released new venture capital funding and recognition from major customers and government agencies fueling an expansion of our staff.

The Job

Senior R&D Project Manager manages multiple suites of projects related to product development and/or production. This role requires an exceptional level of strategic thinking to direct long-term program planning. Managing a program includes drafting/organizing documentation, overseeing the design history file, running program meeting, prioritizing projects and goals on behalf of a larger group, regularly updating timelines to track goals and milestones, facilitating stakeholder communication, guiding the program team through the change management process, and other relevant tasks. PM should have an advanced knowledge of design control, change control, and risk management as they relate to medical device development and/or production.

Senior Project Manager should have experience in leadership positions. This experience is necessary to guide program stakeholders and to serve as a mentor to others on the team.

  1. Perform all work in compliance with company policy and within the guidelines of Specific Diagnostics’ Quality System.
  2. Manage program communication to align stakeholders and track goals/milestones.
  3. Run program meetings independently.
  4. Present program-related updates to large groups and executive groups.
  5. Own and delegate program-related tasks, including (but not limited to): meeting minutes, timeline updates, and presentation preparation.
  6. Utilize knowledge of Specific Diagnostic products, design control, risk management and change control to draft project proposals, design input documentation, project plans, schedules, presentations, technical reviews, etc., and review these types of documents for other members of the team.
  7. Analyze relevant project information (e.g., project status, project issues, etc.), proactively brainstorm and implement solutions to potential roadblocks.
  8. Maintain documentation; ensure that appropriate documentation is complete at project close.
  9. Communicate with program stakeholders to assess and meet program milestones.
  10. Champion the change control process when managing product changes in a program setting.
  11. Draft risk management plans and/or risk assessments. Assist others in drafting their risk management plans and/or risk assessments.
  12. Build relationships with (and maintain the trust of) program stakeholders.
  13. Gather information on program stakeholders’ wants/needs.
  14. Independently manage multiple large/complex programs.
  15. Teach and/or mentor other members of the team.
  16. Navigate design history file (DHF) documentation in an audit
  17. Navigate workflows of other business units/departments to execute a successful project or program.
  18. Own multiple of the following: project plans, design change notices (DCNs), and technical reviews.
  19. Contribute to portfolio and company strategic plan.
  20. Escalate issues in program to executive-level when necessary.
  21. Independently generate (or maintain a significant portion) of the product's DHF.
  22. Negotiate with other departments to align divergent visions.
  23. Pursue growth opportunities for assigned program(s).
  24. Regularly review colleagues' documents and coach verbal communication.

 

Qualifications

Training and Education

Bachelor’s degree required; B.S. in life science, engineering, or equivalent technical field a plus. Relevant advanced, technical degree, MBA, and / or PMP certification from the Project Management Institute is a plus.

 

Experience 

At least seven years of project or program coordinator/management experience. Experience working for a medical device company a plus.

Knowledge, Skills and Abilities

  1. Expert knowledge of Specific Diagnostics products, design control, risk management, and change control.
  2. Self-motivated, and able to manage time effectively.
  3. Can effectively work as part of a team, and supports the team with a helpful attitude.
  4. Clear and transparent verbal and written communication.
  5. Critical listening skills, and an ability to recognize important and high-level information.
  6. Ability to stay positive and calm in stressful situations.
  7. Ability to adjust to changes in scheduling, and general flexibility in the work environment.
  8. Organization and extreme attention to detail.
  9. Ability to complete work quickly and efficiently.
  10. Critical and innovative thinker.
  11. Confidence without arrogance.
  12. Ability to understand multiple perspectives.
  13. Inquisitive and eager to learn.
  14. Comfortable with ambiguity.
  15. Forward thinking.
  16. Can lead the program team in goal-setting and strategic planning.
  17. Strong understanding of how programs fit into the larger portfolio.


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BioMérieux Inc. and its affiliates are Equal Opportunity/Affirmative Action Employers. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran or disabled status, or genetic information. Please be advised that the receipt of satisfactory responses to reference requests and the provision of satisfactory proof of an applicant’s identity and legal authorization to work in the United States are required of all new hires. Any misrepresentation, falsification, or material omission may result in the failure to receive an offer, the retraction of an offer, or if already hired, dismissal. If you are a qualified individual with a disability, you may request a reasonable accommodation in BioMérieux’s or its affiliates’ application process by contacting us via telephone at (385) 770-1132, by email at [email protected], or by dialing 711 for access to Telecommunications Relay Services (TRS).

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