operations engineer Milpitas, CA
Endologix
Full Time
Milpitas, CA
100000 - 85000 USD ANNUAL Today
Job description
Overview:
Position Summary:
At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. We work hard to bring life changing products to patients and believe that a culture which is inclusive of our individual backgrounds and passions will help us create ideas that move all of us forward.
Endologix LLC is a California-based, global medical device company dedicated to improving patients’ lives by providing innovative therapies for the interventional treatment of vascular disease.
We have a therapeutic portfolio designed to treat diseases which currently have clinically relevant unmet needs. Our existing products can treat a wide spectrum of vascular disease through abdominal aortic aneurysms to lower limb peripheral vascular disease. We obtain excellent clinical outcomes through meticulous attention to product design, manufacturing, and training, all backed by industry-leading clinical evidence.
With a robust pipeline of disruptive technology, our vision is to provide physicians with the best device for each patient; because when it comes to ensuring patient well-being, we are never satisfied with the status quo.
Position Summary:
The Quality Operations Engineer will support, plan, manage, and execute the Quality Operations activities to support the manufacturing of vascular devices. This position will aslo plan and implement Quality Operations programs designed to ensure continuous production of products consistent with established standards by performing the duties listed below.
Responsibilities:- Assure that activities are following compliance in the respective areas that are applicable from FDA GMP/GLP, ISO 13485/8, CMDR, CMDCAS, Medical Device Directive, Japan (ordinance 210, GMP, GPMI, Pharmaceutical Affairs Law) and other national and international standards as necessary.
- Provide quality engineering support. Address product related issues arising in the manufacturing clean rooms and assure elements such as NCR, CAPA, audits and scrap are being used properly.
- Perform investigations to determine root cause. Assign and ensure completion of corrective and preventive actions.
- Completes investigations in a timely manner to ensure customer service levels are maintained.
- Coordinates the reporting and provides trend analysis for non-conformance incidences.
- Partner with Manufacturing/Operations, R&D, supply chain and other functions to ensure quality assurance and engineering methods drive the highest quality products and processes from development through manufacturing in accordance with applicable requirements.
- Lead implementation and infusion of quality engineering tools throughout the organization to drive methodical and process-based approaches to product and process development. Utilize same approach to existing products and processes, applying where possible, new technologies and methods.
- Utilize quality toolbox including six sigma methodology, lean principles, advanced statistics, reliability engineering, design assurance techniques, and other proven tools.
- Support sustaining and new product projects.
- Support the manufacturing managers and supervisors in their efforts to ensure production needs are met.
- Determine equipment qualification, process validation, and product line design/modifications requirements. Advise Manufacturing on installation and maintenance of inspection and testing procedures for raw materials, packaging materials, components and finished products. Support design transfer activities.
- Work with Manufacturing to provide feedback to production personnel regarding accuracy of assembly procedures. Work with Facilities to establish and maintain effective environmental monitoring systems.
- Lead development of Risk Management documentation.
- Assist in conducting and documenting process and system audits using specific regulations and company procedures as audit standards.
- Promote and organize training activities related to product quality, cost, reliability, and regulatory compliance. Develop strategies to ensure continuous improvement in the ability to design and manufacturing quality products.
- Maintain an up-to-date knowledge in the techniques of Quality Assurance/Quality Control and in the company products and process technologies.
- Develop systems for the identification, analysis, correction, and prevention of quality issues.
- Work with Quality and the Operations Team to develop a culture of accountability, empowerment, continuous improvement, customer focus, collaboration, and celebration of good work, involvement and development of all people within the team.
- Instill a sense of urgency to ensure goals are met in a timely manner while meeting regulatory and quality standards and customer requirements.
- Be self-directed with the ability to take initiative and be accountable for results, and demonstrate confidence, maturity and integrity.
- Communicate effectively to all levels of an organization.
- Ability to prioritize work activities to ensure critical priorities; those with highest impact on goals.
- Protect Endologix confidential and proprietary information in accordance with Legal guidelines.
- Perform other duties as assigned by supervisor.
- Strong communication and organization skills required.
- Good judgment skills within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
- Flexibility to handle multiple tasks and meet timelines. Normally receives minimal instructions on routine work, general instructions on new assignments.
Education:
- Bachelor of Chemical, Biomedical, Mechanical, Industrial, or Manufacturing Engineering (or related field).
Experience:
- Minimum of two to four (2-4) years’ experience in the Medical Device or Pharmaceutical Industry.
Expected Base Salary: $85,000 - $100,000 (Compensation will be commensurate with experience and expertise.)
At Endologix, we see diversity as an opportunity for employees to bring their worldview, their experiences and their perspectives to work every day. We work hard to bring life changing products to patients and believe that a culture which is inclusive of our individual backgrounds and passions will help us create ideas that move all of us forward.
As a global business, our ability to understand, embrace and operate in a multicultural world – in the marketplace and workplace – is critical to our success. Many employees across the company work diligently to help us advance in our diversity journey. Employee feedback gathered both formally and informally further strengthens our culture of inclusion and collaboration as well as initiatives focused on gender and U.S. ethnicities.
Join us, and bring your point of view, talents and contributions so we can all grow together.
About Endologix
CEO: John Onopchenko
Revenue: $100 to $500 million (USD)
Size: 501 to 1000 Employees
Type: Company - Public
Website: www.endologix.com
Year Founded: 1992
Endologix
www.endologix.com
Irvine, CA
John Onopchenko
$100 to $500 million (USD)
501 to 1000 Employees
Company - Public
Health Care Products Manufacturing
1992
