Mgr. Verification & Validation
Website Draeger Medical Systems, Inc.
Draeger Medical Systems, Inc.
Company : Draeger Medical Systems, Inc.
Country: United States
Location : Andover, Massachusetts
Post: Wed, 01 Feb 2023 20:28:39 GMT
Expires: Wed, 01 Mar 2023 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
Mgr Verification & Validation – Draeger Medical Systems, Inc. – Job-ID V(phone number removed)
The Job Responsibilities
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.
Bachelor’s/Master’s degree in engineering or business, or the equivalent real-world experience required to effectively fulfill this role.
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.
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
The Dräger Workplace
In North America, Draeger employees over 1,400 employees working in our major sites in the United States and Canada (in the US: Andover, MA; Telford, PA; Houston / Coppell, TX, and in Canada: Mississauga, ON), including our Sales and Service workforce employees from coast to coast.
The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.
Equal Opportunity Employer – Disability and Veteran
Who we are
Draeger is a leading international company in the fields of medical and safety technology. Whether in clinical applications, in industry, mining or emergency services: Draeger products protect, support and save lives. That’s what our more than 15,000 employees have been striving for – every day for more than 130 years. Dräger – Technology for Life ®
What we offer
-Education & Training
-Health center and gym
If you have any questions, please contact
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