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.
The Senior Manufacturing Engineer will support the commercial manufacturing organization while enhancing productivity and product quality. The Senior ME takes a proactive stance in improving manufacturing processes, tooling, and fixtures. He/she addresses issues that arise in manufacturing related to raw materials, environmental conditions, operator training, tooling, and other factors that impact product output and quality. He/she interacts and collaborates with Quality Engineers, Operations Staff members, production Manager and supervisors, and Regulatory Affairs, to bring about continuous improvement in Endologix manufacturing.
Design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules
Develop and execute process validation protocols (IQ/OQ/PQ)
Analyze process data and make decisions/recommendations relating to process capability and DFM
Perform Installation Qualification (IQ) equipment protocols and reports
Investigate benefits and features of capital equipment and generate capital appropriation justifications
Create and maintain accurate documentation of concepts, designs concepts, tool drawings and shop orders in coordination with the Quality Assurance and R&D functions
Provide engineering support to production department in troubleshooting and resolving technical problems.
Contact and address component and/or raw material issues with suppliers
Support manufacturing and quality with addressing NCMR issues as an Investigator / Owner
Plan, schedule, and complete projects in a manner consistent with business objectives
Contribute to the intellectual property position of the company via invention and patent applications
Maintain accurate documentation of concepts, designs, and processes.
Maintain current knowledge of medical, technical, and biomedical developments as related to company products.
Support prototype and pilot production of new products, product changes, and enhancements in coordination with the Manufacturing and Quality Control functions.
Work with product development staff to ensure that design for manufacturability principles are applied to new processes and any issues are resolved
Maintain GMP compliance relating to Document Control, R&D, and Quality Assurance
Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations
Ensure that all regulatory and internal policies are followed
Assist engineering manager in development of engineers and technicians, providing assistance with coaching and mentoring
Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
Perform other duties as assigned by supervisor
Exercises judgment within broadly defined practices and policies in selecting methods, techniques, and evaluation criteria for obtaining results.
Has the ability to use moderate to advanced statistical techniques when analyzing data and makes rational and logical decisions based the that analysis
Applicable knowledge of Minitab, JMP, or other statistic tools
Applicable knowledge of SolidWorks or other CAD software (not a requirement but a desirable skill)
May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
Specific Skills, Knowledge & Behaviors
(To perform the job successfully, an individual should demonstrate the following competencies):
Strong interpersonal skills including ability to interact with high degree of diplomacy.
Good project management skills.
Extensive knowledge of global medical device regulations and product development processes.
Comprehensive knowledge of quality systems and relationship to business.
Experience in developing and communicating global regulatory strategies
Provide leadership, creativity, and business acumen when interpreting regulatory standards and guidances.
Ability to work in a fast-paced, technically challenging environment where drive is critical to success
Must be self-motivated and self-disciplined and able to prioritize and handle multiple tasks and responsibilities
Expertise in Microsoft Office applications and charting programs.
Effective problem solving techniques
Excellent applied thinking and technical writing skills
Strong communication and organization skills required.
Supervisor Core Competencies:
Leading Change: Develops and implements strategies and approaches for leading and managing organizational transformation at individual , functional, and enterprise levels, and influences change where needed
Inspiring the Workforce: A compelling storyteller, motivates and engages employees at individual and group levels towards results
Selecting & Developing Talent: Assesses, selects, coaches, mentors, provides constructive feedback, empowers and develops the workforce at individual and group levels
Strategic thinking: Creates the vision and direction, assesses priorities, understands , analyzes, and acts upon drivers of business and operational success at a departmental, functional, and/or enterprise level
Global & systems thinking: Understands and embraces global nuances, leads across functions and geographies, builds alignment across diverse groups , and looks at the company holistically
External Industry Leadership & Knowledge: Connects with and influences health care and/or functional industry regulatory and government organizations, and understands external industry factors that impact the company and products
Continuous Improvement: Leverages best practices tools and methodologies to assess, identify, and executes on opportunities to improve; Focus on learning and building new capabilities into self and team
Problem Solving & Problem Prevention: Uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
Accountability: Drives and focuses on results, takes initiative without direction, takes broad ownership for all work within scope, builds relationships and works across departments, functions, or areas of responsibility
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
Communication: Effectively uses all mediums of communication as appropriate, presents well to groups, actively listens, and continuously identifies opportunities to build communication skills
Collaboration & Teamwork: Actively works together with formal and informal team members to build relationships and achieve team goals
Prioritization: Effectively prioritizes work to ensure timely completion of work within scope
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
Technical Expertise: Continuously builds functional and technical expertise, and pro-actively applies that technical expertise in progressively broader scope
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
Problem Solving & Problem Prevention: Learns and uses strong problem solving methodologies and tools, focuses on root cause analysis, and shows orientation towards problem prevention
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
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