Plant Manager

Posted 12 Hours Ago
Be an Early Applicant
Irvine, CA, USA
In-Office
125K-173K Annually
Senior level
Healthtech • Manufacturing
The Role
Lead a medical device manufacturing site overseeing safety, quality, manufacturing, supply chain, engineering, facilities, and finance. Serve as Value Stream Manager driving continuous improvement, regulatory compliance (FDA, ISO 13485, EU MDR, CMDR), KPI performance (safety, quality, delivery, cost), budget management, and cross-functional alignment to meet productivity and capacity goals.
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 Plant Manager is responsible for developing and implementing strategies and plans to meet short and long-term goals to achieve the highest standards of safety, quality, customer service, and financials for the Integra Lifesciences' medical device manufacturing site.  

They are responsible for all aspects of safety and security, manufacturing, engineering, supply chain, facilities, and oversight for site quality, regulatory, materials, procurement, finance, human resources, product development, distribution, and service as measured by safety, quality, delivery, and cost key performance indicators (KPI's).  In addition, this role leads the plant as the site Value Stream Manager, accountable for end-to-end performance, daily management, and continuous improvement across the site value streams. They ensure the production of medical products in compliance with corporate policies, U.S. Food and Drug Administration regulations, ISO 9001, ISO 13485, EU MDR, the Canadian Medical Device Regulations (CMDR), and other applicable regulatory agencies.

KEY RESPONSIBILITIES

  • Responsible for ensuring the safety of all colleagues and fostering a culture of safety and compliance.  Ensure environmental, health, and safety programs are compliant, effective, and continuously improving.  Ensure accident, near miss, and incident events are managed appropriately and timely, teams are trained appropriately, and proper housekeeping is maintained.
  • Foster a culture of colleague engagement thru positive leadership, recognition, career development, accountability, feedback, continuous improvement, and engagement activities
  • Lead the site in the continual pursuit of a stronger quality culture and a robust quality management system and ensure site's quality standards compliance as defined by Integra’s SOPs, GMP, Global Quality Standards, local and procedures, etc.  Partner with Quality Assurance and Regulatory Affairs to ensure full compliance with applicable standards (FDA QSR, GMP, ISO 13485, etc).
  • Ensures robust defect processing including root cause and sustainable remediations.  Ensure operations remain in controlled and validated state (IQOQPQTMV) and is full compliance with all local regulatory QMS procedures.
  • Foster a continuous improvement culture to advance operational excellence and ensure sustained improvements in manufacturing reliability, throughput, and cost effectiveness.
  • Develop strategies and plans to meet/beat site productivity and service targets leveraging lean six sigma tools and techniques (5S, Kaizen, Value Stream Mapping, Kanban, Standard Work. OEE) to reduce waste and improve operational efficiency.
  • Lead the site as Value Stream Manager, driving end-to-end flow from suppliers through manufacturing to shipment; chair value stream daily/weekly tier meetings; own and improve SQDC metrics (safety, quality, delivery, cost); and align cross-functional teams (operations, engineering, quality, supply chain) on priorities, problem solving, and execution.
  • Fully accountable to site’s financial performance and budget management, including oversight of headcount, operational expenses, and capital investments.  Ensure efficient allocation of resources and alignment of spending with strategic priorities.
  • Develop strategies and plans to meet both short term attainment and fulfillment plans as well as long term capacity plans aligning to enterprise objectives while maintaining flexibility. 
  • Complete other job-related duties as assigned.

Skills & Competencies

  • Engineering or Technical degree with 8+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience OR Master degree with 5+ years of experience leading a team (direct reports or projects) or equivalent education and years of management experience
  • Demonstrate excellent organizational and english communication skills (oral & written)
  • Financial acumen relating to operations profit & loss (P&L) items
  • Proficiency in MS Office Suite and statistical analysis software.
  • Experience in regulated environment; medical device or pharma preferred
  • Familiarity with health, safety, and environmental regulations related to manufacturing.
  • 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.

Salary Pay Range:

$125,350.00 - $172,500.00 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

  • Engineering or Technical degree with 8+ years leading a team OR Master's degree with 5+ years leading a team
  • Experience leading teams (direct reports or projects)
  • Knowledge of FDA QSR, GMP, ISO 13485, EU MDR, CMDR and other applicable regulatory standards
  • Familiarity with environmental, health, and safety regulations related to manufacturing
  • Financial acumen related to operations P&L, budget and capital management
  • Proficiency in MS Office Suite and statistical analysis software
  • Experience in a regulated environment (medical device or pharmaceutical)
  • Demonstrated strong organizational and English communication skills (oral and written)
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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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