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IVD Software Program Manager

Werfen

Bedford, MAOnsitePosted 42 days ago$135,000 - $160,000/year
Full TimeSenior LevelProgram / Project ManagementDiagnostics
Original posting ↗

Summary

Plan and manage small to mid-size product development projects across multiple phases within a large multi-functional product development program; or plan and manage multiple small, related projects which together constitute a program. The position requires enthusiastic leadership skills in a highly technical medical instrument product development environment. The position requires regular interaction with all functions and levels of the organization from R&D scientists and engineers, marketing/sales, quality/regulatory, and operations, through executive management. Under the general oversight of a Senior Program Manager or Director of Programs, this individual directs the project team(s) in a manner to achieve the business results expected.

Job description

Job Summary

Plan and manage small to mid-size product development projects across multiple phases within a large multi-functional product development program; or plan and manage multiple small, related projects which together constitute a program. The position requires enthusiastic leadership skills in a highly technical medical instrument product development environment. The position requires regular interaction with all functions and levels of the organization from R&D scientists and engineers, marketing/sales, quality/regulatory, and operations, through executive management. Under the general oversight of a Senior Program Manager or Director of Programs, this individual directs the project team(s) in a manner to achieve the business results expected.

Key Accountabilities

  • Technical and Project Leadership: Provide technical and team leadership to one or more small project team(s) or a program team, including planning, scheduling, and technical leadership within the program area. Drive the successful attainment of program/project goals.
  • Project Planning and Scheduling: Responsible for project or program planning and scheduling, clarifying and defining scope of work, utilizing deliverable milestone methods and critical path scheduling, conducting resource planning and allocation, and developing task and project estimates. Generates an integrated project plan that meets business objectives and is in compliance with the design control process, while maximizing resource efficiency.
  • Project Execution and Control: Responsible for conducting regular project or program team status meetings and reviews. Ensures deliverables are completed and documented. Identifies the need for and implements changes to the project plan that are within approved project boundaries. Plan and conduct major project milestone reviews.
  • Agile Project Management: Assume the role of Product Owner for Agile teams that are within the program. Define story requirements and approve deliverables at the Sprint demo.
  • Problem Solving Leadership: Responsible for coordination of project resources to identify the root cause(s) of project issues, and develop and manage a plan to fix, test, and implement an appropriate solution through completion.
  • Risk Management Leadership: Responsible for ensuring program and project risks, both technical risks and management risks, are identified and appropriate risk mitigation plans are included within the program and project plan. Regularly assess and report the status of overall program risk remaining on a program.
  • Design Control: Creates and maintains file to current phase ensuring accuracy.
  • Communication: Responsible for program communication for both within the project team(s) and between the team(s) and executive management.
  • Vendor Management: Responsible for ensuring adequate oversight and control of vendors providing development, test or technical services that support the project.
  • Cross Department Collaboration: Coordinates discussions with commercial functions (operations, regulatory, distribution, customer support, marketing, sales, service, affiliates, etc.) through established communication channels to support on market change(s) and/or new product introduction.
  • Conflict Resolution: Able to resolve program and project team conflict through the application of good listening skills and negotiating skills. Able to remove oneself from the problem. Fosters creative, professional climate that will maximize the contributions of the technical staff.

Secondary Functions

  • Project/Program Initiatives: Participates in activities focused on improving the efficiency and effectiveness of the product development processes and procedures.
  • Budget Managed: Prepares and maintains program budget. Annual budget between $2 million and $5 million.

Qualifications

  • BS in STEM field (engineering, chemistry, physics, etc.)
  • Minimum of 7 years in project management or 5 years in product development
  • Experience in design and development of medical instrumentation desirable
  • Certification in project management or program management is desired

Skills & Capabilities

  • Leadership Skills
  • Problem solving, conflict management, listening, managing and measuring work
  • Strong project management skill set and familiarity with project management tools and techniques
  • Team player, self-motivated, perseverance
  • Strong oral and written skills
  • Word, Excel, PowerPoint, Design Control

Travel Requirements: Less than 10% of the time.

Requirements

  • BS in STEM field (engineering, chemistry, physics, etc.)
  • Minimum of 7 years in project management or 5 years in product development
  • Experience in design and development of medical instrumentation desirable
  • Certification in project management or program management is desired
  • Leadership Skills
  • Problem solving, conflict management, listening, managing and measuring work
  • Strong project management skill set and familiarity with project management tools and techniques
  • Team player, self-motivated, perseverance
  • Strong oral and written skills
  • Word, Excel, PowerPoint, Design Control

Benefits

  • Medical, Dental & Vision
  • 401(k) Matching
  • Paid Vacation
  • Sick Leave
  • Performance-based Bonus

Company overview

Werfen is a global leader in specialized diagnostics, founded in 1966 in Barcelona, Spain as a family-owned innovative company. The organization has established itself as a worldwide authority in five key clinical areas: Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant diagnostics. With headquarters in Barcelona and technology centers strategically located in the United States and Europe, Werfen operates directly in 30 countries and serves more than 100 territories through distributors. The company achieved remarkable financial performance with worldwide sales exceeding €2.2 billion in 2024, supported by a workforce of over 7,000 employees globally. Werfen's comprehensive portfolio includes advanced diagnostic systems, reagents, laboratory automation solutions, and point-of-care testing platforms that enable healthcare providers to deliver precise and timely patient care. Their innovative technologies span from blood gas analyzers with hemolysis detection capabilities to automated immunoassay systems and specialized diagnostic assays. As a vertically integrated diagnostics company, Werfen maintains complete control over research, development, manufacturing, and distribution, ensuring quality and reliability across their product lines while continuously advancing diagnostic science to address critical healthcare challenges worldwide.

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