Sr. Manager, Design Assurance & Reliability Engineering

Integra LifeSciences-posted 4 months ago
Full-time • Senior
1,001-5,000 employees
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The Senior Manager of the Tissue Technology (TT) Design Assurance Engineering department is responsible for developing Design Assurance Engineering resources, processes, and tools required to design, develop and commercialize best in class TT product offerings. Duties include strategic planning and budgeting for the function, determining skill needs, talent acquisition, adherence to quality processes, performance management, staff development, and allocation of resources to meet dynamic business needs. Provide technical leadership, assessing technology and industry trends to improve performance in key focus areas such as Risk Management, Product Usability, Change and Design Controls. Provide guidance to and/or lead project teams by participating in business design, technical and gate reviews.

  • Functional Management of the Design Reliability Assurance Engineering Staff of the TT DRA organization
  • Lead the design and development of new or improved products in close collaboration with Product Development, Project Management, Regulatory, Marketing, Corporate and Site QA and Medical Affairs.
  • Interact routinely with R&D Management on matters concerning engineering technologies and development projects.
  • Influence TT Design Assurance functional strategy on matters including core capabilities, product quality, design control processes, resource development and utilization, and engineering practices.
  • Work closely with TT Engineering Managers to establish and align Design Assurance department level plans and objectives with business and R&D strategic plans and objectives.
  • Identify talent and hire associates with the capabilities needed to meet the department objectives.
  • Assess and manage performance and development of associates within the group on an ongoing basis.
  • Set departmental goals based on corporate and divisional initiatives.
  • Provide input into yearly budget planning and ongoing resource planning.
  • Define the engineering capabilities required to meet new product development and remediation objectives.
  • Identify and solve complex, operational and organizational issues, leveraging the appropriate resources within or outside the department.
  • Work with CSS leaders and quality assurance stakeholders to unify processes and tools (where possible) to enable common work practices between the CSS and TT Divisions.
  • Drive Technical and Process Excellence
  • Influence the continuous improvement of the product development process to ensure quality, robust work products via metrics and design assurance processes.
  • Ensure the application of best practice design assurance engineering methods to produce robust design solutions.
  • Drive cross project standardization and maximize component reuse.
  • Influence the selection of appropriate technology, technology and development partners to ensure project success.
  • Ensure compliance to Integra LifeSciences quality standards and conveys an expectation of high product quality.
  • Lead or participate in design, technical and gate reviews.
  • Thoroughly assess the ability of proposed designs to meet specified requirements.
  • Plan and lead technical design assurance activities from concept through successful commercialization, and continuous product improvement within established schedules, budgets, and product cost targets.
  • Provide technical assessments of existing products for consideration in new product development.
  • Review for approval Risk Management Documentation including but not limited to Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis, dFMEA, pFMEA, aFMEA.
  • Participate in design and change control activities.
  • Participate in FDA inspections, ISO Certification and Surveillance audits and Internal audits.
  • Collaborate with other technical disciplines and across business functions to develop comprehensive solutions to design objectives.
  • Form effective working relationships with cross-functional leaders and teams to deliver complete product solutions to the market.
  • Engage with R+D, Marketing, Quality, Regulatory, Planning, Medical Safety, Procurement and Manufacturing groups to understand requirements of stakeholders and customers.
  • Provide high-level technical assessments and communications to functional leadership.
  • Guide Design Assurance team members to evaluate and apply good engineering practices/principles to meet project objectives.
  • Participate in project planning and drive execution to meet project timelines and deliverables.
  • Directly apply design assurance and reliability engineering expertise and experience to execute project assignments.
  • Requires a bachelor’s degree in science, Engineering, Physics or related Engineering discipline or equivalent with 8+ years of experience leading a team (direct reports or projects).
  • Requires master’s degree in science, Engineering, Physics or related Engineering discipline or equivalent with 5+ years of experience leading a team (direct reports or projects).
  • Experience in product development, product realization, design transfer, design verification and validation.
  • Experience leading engineering product development teams, experience in a complex development environment.
  • Minimum of three years of work experience in a regulated environment.
  • Work experience in an FDA/ISO regulated environment preferred.
  • Excellent interpersonal communication skills – verbal, written, and listening.
  • Demonstrated understanding and usage of Microsoft suite (Project, Word, Excel etc.).
  • Demonstrated experience with Configuration Management tools (source code control, defect tracking, etc.).
  • Talent management skills including coaching and mentoring, dealing with conflict management.
  • Manage performance and drive team achievement.
  • Ability to recruit, hire and maintain a high performing staff.
  • Demonstrated leadership skills driving product enhancement and improved reliability projects.
  • Demonstrate strong project management skills utilizing agile development practices.
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