• Job Description

  Req#: JP-004229170

  Job Description

  · Functions as a project engineer for remediation activities

  · Experience authoring and tracing product requirements to system requirements and regulations

  · Coordinates the design with design quality risk, manufacturing, operations and regulatory

  · Effective technical communicator that can translate between technical and business requirements

  · Collaborates with the appropriate subject matter experts to resolve issues

  · Experienced with method development and validation

  · Experienced with statistics

  · Experienced with design controls

  · Experienced working under with quality systems

  Minimum requirements

  BS in Mechanical or Systems Engineering

  • Medical device manufacturing experience a plus
  • Familiarity with regulations and how to decompose into product requirements
  • Coordinates work primarily across functions (Systems, Quality, Regulatory, Mfg, Operations, etc)
  • Communicates proactively and effectively at all levels.
  • Expands understanding and employs sensitivity in communications with culturally diverse audiences.
  • Demonstrates deep/advanced knowledge of specialized discipline and methods, and applicability to specialized product needs to support customer, operational policies and processes
  • Interfaces with suppliers, manufacturing, systems and commercial teams
  • Interfaces with project teams as necessary
  • Develops test protocols; reviews, and rejects or approves test protocols developed by others, documents/reports findings, and provides corrective guidance.
  • Independently researches issues outside technical capability and selects most efficient methods/techniques to achieve objectives.
  • Applies appropriate standards, processes, policies, procedures, practices and tools throughout the product/system development lifecycle, including Standard Operating Procedures (SOP’s), and applicable medical device development protocols under FDA Quality
  • Systems Regulations, CE Marking, and ISO Quality Systems.
  • Independently solves a wide range of complex and diverse problems and evaluates short term impact of recommendations.
  • Leads design reviews at the sub-system level.
  • May assist with systems architecture development at the sub-system level.
  • Works on high impact assignments where speed, quality, and efficiency significantly impacts results.
  • Performs a variety of assignments reflecting proficiency in a broad range of complex topics; balances constraints and opportunities of 1-2 adjacent technical disciplines with primary area of specialization.
  • Performs large or complex portions of projects where responsibility includes definition, completion, technical quality, and securing consistency across assigned areas.
  • May independently lead small technical support projects or coordinate portions of larger projects.
  • Contributes to project strategy and approach to meet target goals and milestones, evaluates resource allocation needs, and monitors project risks to determine best mitigation path.
  • Provides frequent written and oral presentations, status reports, and updates, adapting and developing appropriate formats, presentations and content for a variety of audiences. Assists others with presentations, as requested.
  • Provides technical leadership, trains, mentors, and takes initiative to assist junior staff and others. Troubleshoots complex problems, and engages others in problem solving strategies to obtain practical and effective solutions to complex issues.
  • Evaluates applicability and impact of technical methods and solutions referred by junior staff.

  Diversity, Equity & Inclusion

  At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent
  • Maintaining an inclusive environment through persistent self-reflection
  • Building a culture of care, engagement, and recognition with clear outcomes
  • Ensuring growth opportunities for our people

  Actalent is an equal opportunity employer.

  About Actalent

  Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.

• About the company

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