Sr/Principal Engineer

Our Global Medical Device Client is continue to expand and they are looking for a SR./ Principal Engineer to join their Pittsburgh, PA team. This is a unique opportunity to work in a state-of-art manufacturing facility and to make a difference in the tools used to do patient sample testing.

The candidate will act as program leader for large scale, complex projects relating to product requirements, manufacturing and quality specifications, and product improvements to ensure product line success and growth. Responsible for allocating team resources to produce results that drive product quality, reduce costs and improve customer experience. The role will include fiscal and administrative management accountability, developing and executing strategies in conjunction with management for product improvement.

Responsibilities include cost, schedule, resource allocation, technical direction and quality oversight of programs relating to manufacturing. Working with internal customers, external vendors and stakeholders, is accountable for creation of plan(s) that reflect a total system solution. Ensures proactive project management and coordination of interdisciplinary technical design and integration needs. Establishes and documents problem statement, criteria, scope, and details of all functional efforts. Works with functions to define key needs and performance requirements across all disciplines. Responsible for capturing programmatic risks.

Responsibilities:

  • Achieves goals by driving the cross functional team to measurable and sustainable results that create a business advantage
  • Understands and leverages external entities to produce results in conjunction with business needs
  • Understands and effectively communicates product, timing, financial and program risk
  • Designs solutions in conjunction and within the applicable quality and regulatory framework necessary to meet company and regulatory guidelines
  • Translates identified problems into tactical, cost effective, and feasible plans for execution
  • Identifies resource constraints, provides constructive feedback to team members as well as their supervisors to further team member development and performance
  • Monitors team ‘focus’ and scope to ensure deliverables remain on time and to budget

Experience:

  • 5-7 years Experience in global hemostasis testing, manufacturing or development
  • Previous program or project management experience
  • 2-5 years Experience with medical device and IVD requirements under FDA
  • Quality Systems Regulations, CE Marking, and ISO Quality Systems

Skills:

  • Demonstrated written and oral communication skills along with strong listening skills
  • High degree of technical competency
  • High degree of demonstrated leadership

If interested, please reach out to ecallender@daleyaa.com with you resume.

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