Engineering Controls and Documentation Manager

Engineering Controls And Documentation Manager

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.

Reporting & Management Scope

Supervision Received

Under direct supervision of Director of Global Facilities Engineering

Supervision Exercised

Supervision of contractors / consultants as needed based on project workload.

Key Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Provide technical leadership to ensure the effective coordination and integration of multi-discipline engineering and construction processes and lifecycles.
• Provide oversight 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.

Required Skills & Minimum Qualifications

Education

• Bachelor's degree in an Engineering discipline (e.g., Mechanical, Electrical) or equivalent.

Experience

• 10+ years of experience in engineering, preferably within medical device companies or regulated environments.
• 35 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.

Skills & Competencies

• 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.

Tools And Equipment Used

This role requires regular use of tools and equipment relevant to the work environment. Examples include:

• General office equipment: Computers, printers, copiers, fax machines, and telephone communication systems.

Physical Requirements

The physical requirements listed below represent the motor and physical abilities necessary to successfully perform the essential duties of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform these duties.

While performing the responsibilities of this role, the employee is expected to:

• Sit, listen, speak, and move throughout various areas of the building.
• Travel across all company locations as needed.
• Periodically lift and/or move items up to twenty-five pounds.
• Travel domestically and internationally via car, train, or airplane, as required by the role.

Adverse Working Conditions

The conditions listed below represent environmental factors which the employee may be exposed to while performing the essential duties of this position. These reflect a general plant or service environment.

Adverse exposure may include construction related exposure such as:

• Flammable and corrosive liquids
• Compressed gases
• High temperature steam and water systems
• Construction Equipment
• Medical waste

Appropriate safety protocols and personal protective equipment (PPE) are required and provided. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of the role.

Disclaimer

The responsibilities and duties outlined above are intended to illustrate the general nature and level of work performed by individuals assigned to this position. They do not represent an exhaustive list of all tasks that may be required. Additional duties may be assigned as appropriate to meet business needs.

This job description does not constitute a contract of employment and is subject to change at the discretion of the employer, based on evolving organizational requirements and role expectations.

Salary Pay Range:

$109,250.00 - $149,500.00 USD Salary

Our salary ranges are determined by role, level, and location. Individual pay is determined by several factors including job-related skills, experience, and relevant education or training. In addition to base pay, employees may be eligible for bonus, commission, equity or other variable compensation. Your recruiter can share more about the specific salary range for your preferred location during the hiring process.

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees and/or eligible dependents are eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance, and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, Employees are eligible for the following

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. This site is governed solely by applicable U.S. laws and governmental regulations. If you'd like more information on your rights under the law, please see the following notices: EEO Is the Law | EOE including Disability/Protected Veterans 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 View email address on click.appcast.io.

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.