Engineering Controls and Documentation Manager

Integra LifeSciencesPrinceton, FL
21h$109,250 - $149,500

About The Position

Changing lives. Building Careers. Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what’s possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. The Engineering Controls and Documentation Manager is responsible for overseeing Integra’s engineering project and capital execution controls, policies, procedures, and equipment and facility life cycle documentation. The role will implement and oversee project execution controls including but not limited to specifications, design, cost, schedule and change management. The manager will be required to interact with business groups throughout the Integra corporate structure including facility and operations leadership, legal, quality, and procurement.

Requirements

  • Bachelor’s degree in an Engineering discipline (e.g., Mechanical, Electrical) or equivalent.
  • 10+ years of experience in engineering, preferably within medical device companies or regulated environments.
  • 3–5 years of project management experience in engineering/manufacturing environments, with working knowledge of Engineering Change Controls, ISO, QSR, and design control procedures.
  • Proven ability to manage multiple projects simultaneously.
  • Experience leading cross-functional teams and presenting to senior leadership.
  • Demonstrated flexibility, multitasking, and high performance in dynamic environments.
  • Strong organizational and communication skills.
  • Proficiency in MS Office Suite, CAD and statistical analysis software.
  • Familiarity with health, safety, and environmental regulations related to construction.
  • Self-motivated team player with ability to work independently and collaboratively across all levels of the organization.

Responsibilities

  • Provide technical leadership to ensure the effective coordination and integration of multi-discipline engineering and construction processes and lifecycles.
  • Provide oversite ensuring projects follow engineering methodologies used to plan and monitor capital effectively.
  • Implement necessary systems to define and control capital project Scope, Cost, Schedules and Change Management.
  • Act as the primary interface between the business and outsourced engineering resources.
  • Lead documentation efforts on all aspects of facility engineering, construction and validation across our global presence.
  • Technical lead for electronic management of engineering lifecycle documentation
  • Lead documentation consolidation and enhancement of electronic processes, including documentation structures and storage both physical and electronic means.
  • Ownership of CAD Systems and processes.
  • Perform minor CAD drawing edits and updates.
  • Evaluate and implement technology solutions, such as technical drawing database software or administration platforms, to enhance documentation administration processes, improve data integrity, and increase operational efficiency.
  • Demonstrate a strong work ethic, dependability, accountability, and responsibility, coupled with high organizational skills; capable of multitasking, meeting deadlines, and working under pressure while maintaining a professional attitude; self-motivated and proactive, showing initiative without direct supervision.
  • Demonstrate strong written and verbal communication skills, adept at managing multiple inquiries with time-sensitive deadlines; possesses excellent organizational, time management, and communication skills.

Benefits

  • medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).
© 2024 Teal Labs, Inc
Privacy PolicyTerms of Service