Endologix, Inc

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Director, Manufacturing

Director, Manufacturing

Job ID 
2017-1748
Location 
US-CA-Irvine

More information about this job

Overview

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

 


JOB SCOPE AND PURPOSE:

 

Directs, leads, and controls the day-to-day activities of a mission critical, class III medical device manufacturing plant. Reports to the Vice-President, Manufacturing, and is accountable to establish and ensure that the organization’s initiatives are aligned with global manufacturing and operations strategies/initiatives. Manages direct and indirect subordinates to ensure all metrics including quality metrics and financial goals defined in the Annual Operating Plan are met or exceeded.   Is personally responsible and accountable for motivating staff and broader organization to meet quality, cost, lead-time, productivity, inventory, and delivery requirements. Work in close collaboration and partner with Quality, R&D, Regulatory, HR, and Finance organizations to optimize overall operational efficiency and effectiveness and to develop, modify, and execute company policies that affect local and global manufacturing operations. Ensures lean sigma and operational excellence initiatives are implemented throughout the operation and delivers process and manufacturing excellence by encouraging process and design innovation, supply chain leverage, and cost effectiveness during development and manufacturing. Interacts with senior management or executive levels on matters concerning several functional areas.

Endologix develops and manufactures the latest innovations in endovascular aneurysm repair and sealing. We are a fast-moving, high energy organization. Employees are offered development opportunities and new responsibilities that might have taken them significantly more time in other organizations. Our commitment is to promise the development and refinement of skills while providing competitive compensation and benefits.

Responsibilities

MAJOR DUTIES:

 

To perform this job successfully, an individual must be able to perform each essential job task satisfactorily. The tasks listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

  • Identify, hire, manage, motivate, develop and recognize operations staff; the team may include various levels of managers, supervisors, team leads, and operators.
  • Ensure compliance with applicable policies, local, federal, and international rules and regulations by establishing practices procedures and self-auditing mechanisms.
  • Provide operations direction for cross-functional teams, champion improvements in quality, productivity, service, and cost, and drive towards high performance. Maintain manufacturing strategies for the Irvine Plant, as well as for ensuring alignment with overall company objectives.
  • Collaborate with other functions, such as Quality, R&D, Regulatory and Supply Chain in order to ensure alignment and results.
  • Partner with R&D to ensure readiness and successful integration of new products into the site. Ensure requirements are clearly communicated early in the product lifecycle, and that the plant is doing all possible to establish manufacturability and process capability prior to launch.
  • Review and approve procedures and support documentation in order to support manufacturing and/or project activities.
  • Establish formal and informal feedback mechanisms and frequently monitor execution to ensure compliance with plant requirements and expectations.
  • Develop, submit and/or propose to senior management for consideration and allocation of funds and other resources.
  • Spend majority of time on the production floor and with our production employees, listening to concerns and opportunities, driving high engagement and employee involvement in pursuit of continuous improvement across all areas.
  • Champions efforts to improve the ergonomic impact of our operations and ensures timely and aggressive investigation and corrective/preventive actions for any reported injuries or near misses.
  • Responsible for maintaining a safe work environment free of any harassment, discrimination, and highest ethical/quality standards.  
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ADDITIONAL JOB DUTIES:

  • Represent the company before governmental and non-governmental organizations, chambers, agencies, etc.
  • Champions all efforts to improve the ergonomic impact of our operations and ensures timely investigation and corrective/preventive actions for any reported injuries or near misses.
  • Assists the VP of Manufacturing in developing and managing the Company’s vision, mission, goals, and objectives.
  • Provides input for the development of the Company Strategic Plan.
  • Approves, influences and oversees the annual expense budgets for areas of responsibility and provides signature approval.
  • Perform other duties as required or assigned.

Qualifications

 

QUALIFICATIONS

 

Minimum Education:

 

 

Bachelor's degree from an accredited college or university in engineering, industrial management or other appropriate field is required. Masters of Science (MS) degree or Masters of Business (MBA) preferred.

 

Minimum Experience:

 

 

·         10+ years of progressive operations/engineering leadership experience in an FDA regulated environment with prior experience as a value stream, plant manager or equivalent. Must have a strong blend of technical and business experience.

·         Must have successful leadership experience and track record developing teams and employee engagement; project management; working effectively with cross-functional teams, organizational transformation and cost reduction.

·         Strong understanding of regulatory requirements (International Organization for Standardization (ISO 13485 and other associated or applicable standards)/applicable European Norm (EN) documents/ European Medical Device Directive (MDD)/ Canadian Medical Device Regulation (CMDR) standards/ applicable sections, Quality System Regulation (21CFR 820, 21CFR 11 and other associated or applicable FDA regulations), Japan Pharmaceutical Affairs Law (JPAL). Strong understanding of Design Control, Process Development and Process Validation required.

·         Strong understanding of Lean Manufacturing, Six Sigma and Design for Manufacturing required. Knowledge and experience in automation, process improvement, lean and simplification, as well as in technology transfers is required. Black Belt or Master Black Belt certification preferred.

·         Previous exposure to ERP systems and have understanding of MRP operational philosophy.

·         Must be self-motivated, have good interpersonal and managerial skills, capable of analyzing and solving complex problems through innovative thought and experience.

 

Specific Skills, Knowledge & Behaviors

 

(To perform the job successfully, an individual should demonstrate the following competencies):

 

Core Competencies:

1.     Interpersonal Effectiveness: Actively seeks to understand perspectives and interpersonal needs and expectations of others at all levels, builds self awareness, flexes personal style appropriately, and works through conflicts constructively and appropriately

2.     Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills

3.     Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals

4.     Prioritization: Effectively prioritizes work to ensure timely completion of work within scope

5.     Global & Systems Thinking: Continuously seeks to learn about and embrace global nuances, works across functions and geographies, seeks to align with diverse groups, and seeks to understand interdependencies and impacts of actions across functions and the company

6.     Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope

7.     Continuous Improvement: Learns and uses best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self

8.     Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention

9.     Accountability: Focuses on results, takes initiative without direction, takes ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility

 

Equipment Use & Abilities Required:

 

·         Equipment Use:   Copy machines, fax machines, calculators and personal computers and computer terminals.

·         Computer Skills: Software proficiency in Microsoft Office Suite Required, Applicable knowledge of Minitab, JMP, or other statistic tools software preferred. Applicable knowledge of Solidworks or other CAD software preferred.

·         Language Skills:   English required. Additional languages preferred.

·         Mathematical Skills:   Advanced math skills consistent with an engineering university curriculum. The ability to use moderate statistic techniques when analyzing data and make rational and logical decision base the that analysis

·         Reasoning Ability: Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results. Manages engineering staff and projects of diverse scope in which analysis of data requires evaluation of identifiable factors.

·         Other Skills: Strong communication, project management, cross-functional partnering and influencing skills required.

 

WORK ENVIRONMENT & PHYSICAL DEMANDS OF THE JOB:

 

The noise level in the work environment is usually quiet. While performing the duties of this job, the employee is regularly required to sit; use hands and fingers; talk or hear. The employee is occasionally required to reach with hands and arms and to move within and between the buildings. A computer terminal is used to access, input, and retrieve data. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision.

 

Endologix, Inc. is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex including sexual orientation and gender identity, national origin, disability, protected Veteran Status, or any other characteristic protected by applicable federal, state, or local law.

 

If you are a qualified individual with a disability or a disabled veteran, you have the right to request an accommodation if you are unable or limited in your ability to use or access our career center as a result of your disability. To request an accommodation, contact a Human Resources Representative at Endologix Global Headquarters at 949-595-7200 or Endologix Santa Rosa Facility at 707-543-8800