IVD Software Program Manager

Werfen; Bedford (MA); On-site; USD 135,000 - 160,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401k plan retirement benefits with employer match

Paid vacation and sick leave

Job summary

Werfen, based in Bedford, Massachusetts, is seeking a Project Manager for product development. This role involves leading project teams, managing budgets, and ensuring successful product development. Candidates should have a strong background in project management with at least 7 years of experience, preferably in medical instrumentation.

The position offers an annual salary range of $135,000 to $160,000 and benefits including medical, dental, and 401k matching. We're committed to fostering a diverse workplace and encourage applications from all qualified individuals.

Qualifications

• Minimum of 7 years in project management or 5 years in product development experience.
• Experience in the design and development of medical instrumentation is desirable.
• Certification in project management or program management is preferred.

Responsibilities

• Plan and manage small to mid-size product development projects.
• Provide technical and team leadership to project teams.
• Responsible for project planning, scheduling, and execution.

Skills

Project management

Leadership skills

Problem solving

Conflict management

Strong communication

Education

BS in STEM field (engineering, chemistry, physics, etc.)

Tools

Word

Excel

PowerPoint

Design Control

Job description

About the Position

Werfen is a growing, family‑owned, innovative company founded in 1966 in Barcelona, Spain. We are a worldwide leader in specialized diagnostics in the areas of Hemostasis, Acute Care Diagnostics, Transfusion, Autoimmunity, and Transplant. Through our Original Equipment Manufacturing (OEM) business line, we research, develop, and manufacture customized assays and biomaterials. We operate directly in 30 countries, and in more than 100 territories through distributors. Our Headquarters and Technology Centers are located in the US and Europe, and our workforce is more than 7,000 strong.

Our success comes from a specific focus in these rapidly evolving diagnostic areas, our commitment to customers, and our dedication to innovation and quality. We're passionate about providing healthcare professionals the most valuable and complete solutions to improve hospital efficiency and enhance patient care.

Overview

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. Seeks and receives guidance on unusual and complex problems whose solution exceeds the approved project or program boundaries. Authority of position is that required to carry out assigned duties, except where expressly reserved by the senior management personnel or Werfen Corporate /Divisional Policy.

Responsibilities

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

Networking/Key Relationships

To be determined based on department needs, to include interactions such as:

• Coordination of review of documentation with Quality and Regulatory disciplines
• Communication of product changes with Manufacturing / Operations disciplines
• Communication of plans and status of projects with Marketing discipline
• Communication of plans and status with other programs and projects within R&D

Qualifications

Minimum Knowledge & Experience Required for the Position:

• 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.

The annual base salary range for this role is currently $135,000 to $160,000. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.

This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance‑based bonus.

Equal Opportunity Employer

Werfen is an Equal Opportunity employer and is committed to a diverse workplace. Werfen strictly prohibits unlawful discrimination, harassment or retaliation based upon an individual's race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other protected characteristic as defined by applicable state or federal law. If you have a disability and need an accommodation in relation to the online application process, please contact [e-mail] for assistance.