Integra LifeSciences · 1 day ago
Sr. Manager, Design Assurance & Reliability Engineering
Princeton, NJ
Full-time
Onsite
Senior Level
$125K/yr - $172K/yr
5+ years expIntegra LifeSciences is a company focused on creating change and shaping the future of healthcare. They are seeking a Senior Manager for the Tissue Technology Design Assurance Engineering department to develop resources and processes for best-in-class product offerings, while providing technical leadership and managing a team.
BiotechnologyHealth CareLife ScienceMedicalMedical Device
Responsibilities
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
Requires the ability to change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship
Provides input into yearly budget planning and ongoing resource planning
Define the engineering capabilities required to meet new product development and remediation objectives
Identifies and solves 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
Ensures compliance to Integra LifeSciences quality standards and conveys an expectation of high product quality
Apply Design Assurance Expertise in a Leadership Role
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
Qualification
Required
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
Benefits
Medical
Dental
Vision
Life insurance
Short- and long-term disability
Business accident insurance
Group legal insurance
Savings plan (401(k))
Company
Integra LifeSciences
Integra LifeSciences is an integrated medical device company.
1001-5000 employees
H1B Sponsorship
Integra LifeSciences has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (4)
2024 (5)
2023 (4)
2022 (7)
2021 (5)
2020 (4)
Funding
Current Stage
Public CompanyTotal Funding
$350M2018-05-15Post Ipo Equity· $350M
1995-08-25IPO
Leadership Team
Mojdeh Poul
Chief Executive Officer
Lea Knight
EVP and Chief Financial Officer
Recent News
Integra LifeSciences Holdings Corporation
2025-12-02
Company data provided by crunchbase