Manager, Calibration & Metrology

Posted 5 Days Ago
Be an Early Applicant
Plainsboro, NJ, USA
In-Office
109K-150K Annually
Senior level
Healthtech • Manufacturing
The Role
Leads the site calibration and metrology program for approximately 2,500 assets and 3,000 annual calibration events. Manages technicians, contractors, vendors, budgets, staffing, KPIs, CMMS records, audit readiness, procedures, out-of-tolerance investigations, calibration intervals, and compliance with FDA, GMP, ISO 13485, and ISO 9001 requirements. Serves as the site metrology expert for measurement uncertainty, traceability, calibration standards, and continuous improvement.
Summary Generated by Built In

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 Manager, Calibration & Metrology is responsible for providing technical leadership and operational management of the site calibration and metrology program while fulfilling Senior Metrology Engineer and Calibration Engineer responsibilities. The role ensures compliance with FDA, GMP, ISO 13485, ISO 9001 and applicable regulatory requirements.

REPORTING & MANAGEMENT SCOPE

SUPERVISION RECEIVED

Under direct supervision of the Director, Engineering

SUPERVISION EXERCISED

Position will directly manage Calibration Technicians, CMMS resources, contractors and calibration service providers.

KEY RESPONSIBILITIES

  • Lead the site calibration and metrology program supporting approximately 2,500 assets and over 3,000 annual calibration events.
  • Manage departmental goals, budget, staffing, KPIs and audit readiness activities.
  • Serve as site metrology expert for measurement uncertainty, traceability and calibration standards.
  • Lead out-of-tolerance investigations and calibration interval optimization.
  • Develop, approve, and maintain calibration procedures and work instructions.
  • Oversee vendor calibration providers and calibration certificate review.
  • Manage CMMS asset records, scheduling, recalls, onboarding and retirement of assets.
  • Lead supervisor and technicians, and support continuous improvement, compliance, and safety initiatives.
  • Complete other job-related duties as assigned.

Skills & Competencies

  • Bachelor’s degree in related discipline with 8+ years leading a team (direct reports) or equivalent education and years of management experience.
  • Deep knowledge of metrology principles and various calibration techniques.
  • Proficiency with calibration management software (e.g., ProCal, Blue Mountain).
  • Ability to read and interpret engineering drawings, technical manuals, and schematics.
  • Strong knowledge of FDA, GMP, ISO 13485, measurement uncertainty, MSA, and technical writing.
  • Demonstrate excellent organizational and English communication skills (oral & written)
  • Financial acumen relating to investment opportunities, continuous improvement P&L impacts, etc.
  • Proficiency in MS Office Suite and statistical analysis software.
  • Experience in regulated environment; medical device or pharma preferred.
  • 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.
  • Software and systems: CMMS systems, QMS software, ERP systems, calibration standards, pressure, temperature, electrical and dimensional calibration equipment.

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 25 pounds.
  • Travel domestically and internationally via car, train, or airplane, as required by the role.

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 Total Rewards | Integra LifeSciences

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 [email protected].

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.

Integra - Employer Branding from Integra LifeSciences on Vimeo

Skills Required

  • Bachelor's degree in a related discipline or equivalent education and management experience
  • 8 or more years of experience leading a team with direct reports, or equivalent management experience
  • Deep knowledge of metrology principles and calibration techniques
  • Proficiency with calibration management software such as ProCal or Blue Mountain
  • Ability to read and interpret engineering drawings, technical manuals, and schematics
  • Strong knowledge of FDA, GMP, ISO 13485, measurement uncertainty, MSA, and technical writing
  • Excellent organizational and English oral and written communication skills
  • Financial acumen related to investment opportunities, continuous improvement, and P&L impacts
  • Proficiency with Microsoft Office Suite and statistical analysis software
  • Experience working in a regulated environment
  • Experience in the medical device or pharmaceutical industry
  • Ability to work independently and collaboratively across organizational levels
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The Company
HQ: Princeton, New Jersey
3,489 Employees

What We Do

Integra LifeSciences, a world leader in medical technology with headquarters in Princeton, New Jersey, was founded in 1989 with the acquisition of an engineered collagen technology platform used to repair and regenerate tissue. Since then, Integra has expanded its base regenerative technology product portfolio to include surgical instruments, neurosurgical products and advanced wound care products, through global acquisitions and development of new and innovative products and technologies to address unmet patient needs and improve outcomes. Integra is a global leader in neurosurgery and offers a broad portfolio of products and solutions for dural access and repair, cerebral spinal fluid management and neuro-critical care. Our regenerative tissue technologies include products that address soft tissue, nerve and tendon repairs and for the treatment of acute and chronic wounds, burns, as well as for plastic and reconstructive surgery. The company has offices, manufacturing and research facilities in Asia, Australia, Europe, Middle East, and the Americas. Integra products are ubiquitous in many hospital intensive care units and operating rooms around the world. Some of our high quality leading brands include AmnioExcel®, Bactiseal®, CerebroFlo®, CereLink® Certas® Plus, Codman®, CUSA®, Cytal®, DuraGen®, DuraSeal®, Gentrix®, ICP Express®, Integra®, MatriStem® UBM, MAYFIELD®, MediHoney®, MicroFrance®, MicroMatrix®, NeuraGen®, NeuraGen® 3D, PriMatrix®, SurgiMend®, TCC-EZ® and VersaTru® and are available through a combination of directly employed sales representatives, distributors and wholesalers

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