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SUMMARY DESCRIPTION

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.

ESSENTIAL DUTIES AND 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.  

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill and/or ability required for his position.

Education & Experience:

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.

Skills/Knowledge:

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.

TOOLS AND EQUIPMENT USED

Ability to utilize a computer, telephone, fax and copy machine as well as other general office equipment. Strong computer skills are required.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include but are not limited to the motor/physical abilities and skills required of position in order to successfully undertake the essential duties and responsibilities of this position.  In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly sit, listen, speak, type and move throughout the facility.  Must be capable of using a keyboard for computer purposes.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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Integra LifeSciences is committed to provide qualified applicants and employees who are disabled veterans or individuals with disabilities with needed reasonable accommodations in accordance with the ADA. If you have difficulty using our online system due to a disability and need an accommodation, please email us at careers@integralife.com.

Unsolicited Agency Submission

Integra LifeSciences does not accept unsolicited assistance from search firms for employment opportunities. All CVs/resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. A formal written agreement is required before engaging any agency, and it must be executed and authorized by the Vice President, Talent Acquisition. Where agency agreements are in place, introductions (the initial sharing of a candidate’s name, resume, or background) are position-specific and may only occur within the scope of that approved agreement. Please, no phone calls or emails.

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