manufacturing 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 Manufacturing Engineer will design and develop manufacturing processes, tooling, and fixtures in order to meet daily production schedules while enhancing productivity and product quality. This position will also support new product transfers to manufacturing.
Responsibilities:- Design and develop manufacturing processes for new products, product changes and enhancements, and related tooling and fixtures which are consistent with a zero defect level as well as low product cost.
- 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.
- Perform Installation Qualification (IQ) equipment protocols and reports.
- Provide engineering support to production department in troubleshooting and resolving technical problems.
- Coordinate work with outside vendors, assigned technicians and tool room personnel.
- Plan and schedule projects in a manner consistent with corporate objective.
- 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.
- Provide engineering support to production department in troubleshooting and resolving technical problems.
- Work with new product development staff to ensure that new manufacturing processes are designed for manufacturability, help resolve issues.
- Maintain GMP compliance in coordination with the Document Control, R&D, and Quality Assurance functions
- Complete accurate and timely manufacturing documentation including manufacturing procedures, materials records, etc.
- Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA regulations.
- Ensure that all regulatory and internal policies are followed.
- Identifies hazards and mitigates risk associated with identified hazards in Process FMEA.
- Works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors.
- Exercises judgment within broadly defined practices and policies in selecting methods, techniques and evaluation criteria for obtaining results.
- May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel.
- Utilizes Solid Works drafting skills when appropriate.
- Perform other duties as assigned by supervisor.
- Requires a Bachelor degree or equivalent in engineering or related discipline.
- Masters preferred.
- Requires a minimum of 5 years related experience.
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
