Mgr. Validation & Verification

• Daily management of junior and mid-level staff which includes assignment of work and communicating role accountabilities,  participating in the recruitment of new team members, and performance assessment and management that motivates and builds trust and team collaboration resulting in the accomplishment of established annual goals.  Mentor team members regarding various topics relevant to verification and validation responsibilities, including verification approaches, project deliverables, standards and regulatory compliance, and other relevant topics.
• Coordinate the clarification, alignment, and optimization for projects requiring V&V/PQ engineers for various programs, working collaboratively with various constituencies (PM, PMO, SE, RM, CE, SW, HW, QA, RA, etc.) to ensure business objectives are realized by delivering solutions on schedule.
• Collaborate with partner organizations to ensure key deliverables, dependencies, and constraints are identified, and develop strategies and plans for the V&V/PQ team to effectively track and deliver project commitments on schedule.
• Develop the overall PQ strategy/approach for assigned projects, with consideration for the overall product lifecycle, inclusive of the automation strategy.
• Proactively identify key constraints and opportunities for optimization throughout the product development lifecycle, and design and implement approaches to accelerate time-to-market objectives. 
• Identify and resolve challenges impacting business commitments and key deliverables, including issues with build/verification management, equipment needs, and lab/network infrastructure.
• Ensure all equipment (Dräger products, tools, simulators/emulators, etc.) required for project realization is available, properly calibrated, and appropriately documented.
• Create and improve training material(s) and approaches for V&V/PQ engineers to ensure team capabilities and skillsets are continuously improved (engineering/verification best practices, Agile development, cybersecurity, and relevant standards and regulatory guidance, etc.).
• Perform other duties as needed and assigned.

Education:

Associate's or Bachelor’s/Master’s degree in engineering or business, or the equivalent real-world experience required to effectively fulfill this role.

Related Experience:

5+ years working with verification and validation teams to successfully deliver projects in the medical device or related regulated field. 3+ years in a team lead or project management capacity.

Special Competencies or Certifications:

Demonstrated understanding of key standards and regulatory guidance relevant to the medical device industry. This includes relevant FDA and other regulatory guidance, inclusive of 13485:2016, IEC 62304, ISO 14971, EU MDR, etc.

Agile certification(s): Certified Scrum Master, SaFE (Scaled Agile Framework), etc. preferred.

Draeger has several sites located across North America as well as field-based sales and service positions. Our North America headquarters is located in Telford, PA just north of Philadelphia. We also have US sites in Andover, MA, and Houston, TX. Our Canada site is located in Mississauga, Ontario.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

EEO is the Law

Draeger is an Equal Opportunity Employer. To learn more: Know Your Rights: Workplace Discrimination is Illegal (dol.gov)

From hospitals to fire departments to industrial customers, people around the world rely on our products: cutting-edge technology that combines real engineering with the digital future. With over 130 years of experience, passion and the bold ideas of more than 16,000 employees, we are committed to turning technology into ›technology for life‹.