We are seeking an energetic and results-oriented Senior Program Manager to join our growing team. This position will be responsible for the planning, scheduling, monitoring, reporting and other operational/tactical initiatives necessary to advance the development?of our engineering product pipeline.
This is an exciting, collaborative and highly impactful role that will work closely with program team members and other cross-functional colleagues to ensure detailed planning and tracking of all program related activities and milestones, integration of all functional/department plans into program-level views, and identification and resolution of resource requirements and issues. Position will also provide scenario planning to support comprehensive and robust decision making through in-depth analysis of program activities. These responsibilities could span from product concept initiation through global commercialization.
Directly manage product development programs, including new product development and sustaining development for commercialized products.
Partner with functional leads to establish program timelines, logistics, dependencies, resource planning, and development phase deliverables.
Manage the operational aspects of the programs, including monitoring key milestones, decision points and critical path activities to drive delivery of project objectives.
Communicate program and project status and proactively identify resources necessary to meet established timelines.
Maintain and communicate the master program schedule, budget, and tactical planning.
Lead programs through design input, design output, verification, validation, regulatory approvals (including FDA submission and CE Marking), product launch, and 1-year post-launch period.
Conduct program and project-level risk assessment and define risk mitigation and contingency plans; constantly drive the teams on how to meet the ?time-to-market? goal, and ensure the products meet the regulatory and quality standards.
Work closely with science, engineering, software development, operations, clinical and regulatory, and marketing teams to ensure alignment on project schedules and resourcing.
Collaborate with Marketing, Quality, Regulatory and Clinical departments to ensure successful clinical trial planning and execution.
Collaborate with Marketing, Sales, Regulatory, and Legal departments to ensure successful product launch and post-launch execution.
Maintain an exceptional program management process that is fully compliant with FDA and ISO Design Controls and Risk Management regulations.
Skills and Experience:
MS or BS in an Engineering discipline and/or equivalent experience required.
Minimum of 3-5 years? program or project management experience in medical device, instrumentation or diagnostic development projects strongly preferred.
Familiarity with IVD industry or product lines in the areas of infectious disease, immunoassays or Hemostasis, and blood products strongly preferred.
Experience influencing highly cross-functional, interdisciplinary teams required.
Solid understanding of scientific, regulatory, clinical, quality and process development aspects of product development.
Working knowledge of 21 CFR Part 820 and ISO 13485:2012 regulations.
Solid understanding of product launch processes helpful.
Late-stage development experience in FDA-approved products (e.g. design control, development, verification, validation, life cycle management) helpful.
Critical thinker with the ability to analyze complex inputs and understand broad implications of team decisions.
A positive attitude and proactive approach to problem solving.
Strong work-ethic and ability to produce high-quality work under tight deadlines.
Must have a strong sense of ownership and commitment on assigned programs; must be willing and capable of driving the assigned projects at both the strategic and tactical level.
Understanding of quality control and documentation of protocols and results in a FDA regulated environment.
Excellent organizational, record keeping and communication skills (verbal and written), strong presentation skills necessary.